<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484636</url>
  </required_header>
  <id_info>
    <org_study_id>PLATON pilot-study</org_study_id>
    <secondary_id>AIO-HEP/STO-0219/ass</secondary_id>
    <nct_id>NCT04484636</nct_id>
  </id_info>
  <brief_title>PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)</brief_title>
  <acronym>PLATON</acronym>
  <official_title>PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) A Multicenter, Prospective, Cohort Study To Assess The Genomic Profiles And Associated Therapy Decision In Gastrointestinal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PLATON (Platform for Analyzing Targetable Mutations) is a prospective, multicentre,&#xD;
      observational cohort study with biobanking. In a first approach PLATON's pilot-study assesses&#xD;
      genomic profiling in gastrointestinal cancer therapy and the frequencies of targetable&#xD;
      mutations including Tumor Mutational Burden (TMB) and Microsatellite Instability Status&#xD;
      (MSI), performing Next-generation deep sequencing (NGS) using the Foundation Medicine assays&#xD;
      on tumor specimen and EDTA-whole blood samples. The Study Protocol does not define any&#xD;
      further medical intervention or evaluate the efficacy or safety of the treatment decision&#xD;
      made by the investigator. Another important objective of PLATON's pilot project is to&#xD;
      evaluate whether and how many patients are treated based on their genomic profiles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PLATON (Platform for Analyzing Targetable Mutations) is designed to improve personalized&#xD;
      therapy for patients in different cancer entities, such as in hepatocellular cancer (HCC),&#xD;
      intra- and extrahepatic cholangiocellular carcinoma (CCA), gallbladder carcinoma (GBCA),&#xD;
      pancreatic cancer (PanCa) and esophagogastric cancer (EC/GC), and elevate the treatment&#xD;
      guidance within its framework. The key to understand the mechanisms in initiation,&#xD;
      progression and response to treatment of cancer is the data integration of genetic mutational&#xD;
      signatures with medical and physiological data of diseased cohorts.&#xD;
&#xD;
      PLATON is a prospective, multicentre, observational cohort study with biobanking and does not&#xD;
      define any medical intervention or evaluate the efficacy or safety of the treatment decision&#xD;
      made by the investigator.In a first approach PLATON's pilot-study assess genomic profiling in&#xD;
      gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor&#xD;
      Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing&#xD;
      Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen&#xD;
      and EDTA-whole blood samples. Another important objective of PLATON's pilot project is to&#xD;
      evaluate whether and how many patients are treated based on their genomic profiles.&#xD;
&#xD;
      The pilot-study starts with the national-wide enrolment of 200 participants of both sexes and&#xD;
      ages over 18 at 40 german study sites. The long-term vision is to enable cancer patients to&#xD;
      receive the best available, scientifically founded, biomarker-based care, tailored to his or&#xD;
      her individual needs&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Experimental Study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer</measure>
    <time_frame>up to 4 weeks after biospecimen provision</time_frame>
    <description>Relative frequency of targetable mutations (incl. TMB and MSI status) computed as the number of patients who harbors at least one mutation divided by the number of total patients in the pooled patient population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA</measure>
    <time_frame>up to 4 weeks after biospecimen provision</time_frame>
    <description>Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group</measure>
    <time_frame>up to 4 weeks after biospecimen provision</time_frame>
    <description>Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients receiving therapies in accordance to their genomic profiles</measure>
    <time_frame>up to 4 weeks after biospecimen provision</time_frame>
    <description>Number of patients receiving therapies in accordance to their genomic profiles</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Hepatocellular Cancer</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Gallbladder Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Oesophageal Cancer</condition>
  <condition>Stomach Cancer</condition>
  <arm_group>
    <arm_group_label>Hepatocellular Cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>molecular profiling - hepatocellular cancer (HCC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gallbladder Cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>molecular profiling - gallbladder carcinoma (GBCA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreatic Cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>molecular profiling - pancreatic cancer (PanCa)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oesophageal Cancer + Stomach Cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>molecular profiling - esophagogastric cancer (EC/GC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FoundationOne®CDx and FoundationOne®Liquid</intervention_name>
    <description>FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.</description>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_label>Gallbladder Cancer</arm_group_label>
    <arm_group_label>Hepatocellular Cancer</arm_group_label>
    <arm_group_label>Oesophageal Cancer + Stomach Cancer</arm_group_label>
    <arm_group_label>Pancreatic Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of hepatocellular carcinoma or intra-/extrahepatic&#xD;
             cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or&#xD;
             esophagogastric adenocarcinoma in the advanced setting and no local curative therapy&#xD;
             available.&#xD;
&#xD;
          -  Standard first line therapy is planned, or patient is currently receiving first line&#xD;
             therapy (started within the last 2 months before enrolment)&#xD;
&#xD;
          -  ECOG 0-2&#xD;
&#xD;
          -  Life expectancy ≥ 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to understand all implications of study participation&#xD;
&#xD;
          -  No written informed consent&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salah-Eddin Al-Batran, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institut für Klinische Krebsforschung IKF GmbH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arndt Vogel, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arndt Vogel, Prof. Dr.</last_name>
    <phone>+4969-7601-4420</phone>
    <email>vogela@me.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bianca Zäpf</last_name>
    <phone>+4969-7601-4636</phone>
    <email>zaepf.bianca@ikf-khnw.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>KHNW Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60488</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thorsten Götze, Prof.</last_name>
    </contact>
    <contact_backup>
      <last_name>Ulli Bankstahl</last_name>
    </contact_backup>
    <investigator>
      <last_name>Thorsten Götze, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Timursah Habibzade, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hannover Medical School</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arndt Vogel, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Bianca Lavae-Mokhtari</last_name>
    </contact_backup>
    <investigator>
      <last_name>Arndt Vogel, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anna Saborowski, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Friedrich-Ebert-Krankenhaus Neumünster</name>
      <address>
        <city>Neumünster</city>
        <state>Schleswig-Holstein</state>
        <zip>24534</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siegfried Haas, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Stefan Mahlmann, Dr.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Kristin Bajorat</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Zimmermann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karsten Hamann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Bad Saarow</name>
      <address>
        <city>Bad Saarow</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Pink, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Simone Micheel</last_name>
    </contact_backup>
    <investigator>
      <last_name>Daniel Pink, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Janina Bertz-Lepel, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antje West, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Bayreuth</name>
      <address>
        <city>Bayreuth</city>
        <zip>95445</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Kiani, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Nadine Zeitler</last_name>
    </contact_backup>
    <investigator>
      <last_name>Alexander Kiani, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carla Dorn</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martina Katzenberger</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Werner Kippes</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Viktor Martens</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Melanie Wiederseiner</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Urlah Mbour</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum Spandau</name>
      <address>
        <city>Berlin</city>
        <zip>13585</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Eucker, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Juliane Skerra</last_name>
    </contact_backup>
    <investigator>
      <last_name>Jan Eucker, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jörg-Christian Rath, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Annegret Kunitz, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anna Kohlhaas, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominik Modest, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Susanne Grüneberg</last_name>
    </contact_backup>
    <investigator>
      <last_name>Dominik Modest, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sebastian Stintzing, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Annika Kurreck, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Evangelisches Waldkrankenhaus Spandau</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silke Polata, Dr</last_name>
    </contact>
    <contact_backup>
      <last_name>Ute Moritz</last_name>
    </contact_backup>
    <investigator>
      <last_name>Silke Polata, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristin Lindemann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MVZ Oskar-Helene-Heim Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Schuler, Dr. med.</last_name>
    </contact>
    <contact_backup>
      <last_name>Leffers Elvira</last_name>
    </contact_backup>
    <investigator>
      <last_name>Markus Schuler, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philipp Kiewe, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Augusta-Kranken-Anstalt Bochum</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dirk Behringer, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Dorothee Henzler</last_name>
    </contact_backup>
    <investigator>
      <last_name>Dirk Behringer, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Annette Nolte, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Iris Dieck-Stiller</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anna E Zdebik</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tanja Woiwod</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefan Lukic</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bochum Uni</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Pohl, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Julia Buß</last_name>
    </contact_backup>
    <investigator>
      <last_name>Michael Pohl, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Deepak Vangala, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jack Chater, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Katja Schaarschmidt</last_name>
    </contact_backup>
    <investigator>
      <last_name>Jack Chater, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hagen Rudolph, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ilja Kubisch, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Darmstadt</name>
      <address>
        <city>Darmstadt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helga Bernhard, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Cora Schwebel-Kottke</last_name>
    </contact_backup>
    <investigator>
      <last_name>Helga Bernhard, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rainer Schuker, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephan Schäfer, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Petra Dörner-Mann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thorsten Wenzel, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Corinna Gobst, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tu-Anh Dang, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GEFOS - Gesellschaft für onkologische Studien Dortmund</name>
      <address>
        <city>Dortmund</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clemens Schulte, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Monika Ludwig, Dr.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Clemens Schulte, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jörg Lipke, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christiane Dr. Christiane Bernhardt, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniela Collette</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandra Ketzler-Henkel</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Onkozentrum Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steffen Dörfel</last_name>
    </contact>
    <contact_backup>
      <last_name>Franziska Schwarzbach</last_name>
    </contact_backup>
    <investigator>
      <last_name>Steffen Dörfel</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Göhler, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sebastian Thiele, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Susann Melzer, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Boldt</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Frankfurt Höchst</name>
      <address>
        <city>Frankfurt</city>
        <zip>65929</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hans-Günter Derigs, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Kim-Cybil Hermann</last_name>
    </contact_backup>
    <investigator>
      <last_name>Hans-Günter Derigs, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Felicitas Scholten, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Fulda</name>
      <address>
        <city>Fulda</city>
        <zip>36043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Dickhut, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Christine Lochner</last_name>
    </contact_backup>
    <investigator>
      <last_name>Andreas Dickhut, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe Kostrewa, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heinz-Gert Höffkes, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ulrich Bonse-Geuking, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MVZ Onkologische Kooperation Harz</name>
      <address>
        <city>Goslar</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark-Oliver Zahn, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Alexandra Hess</last_name>
    </contact_backup>
    <investigator>
      <last_name>Mark-Oliver Zahn, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Timo Kambach, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bijan Zomorodbakhsch, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Stolze, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle (Saale)</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petra Büchner-Steudel, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Susanne Behl</last_name>
    </contact_backup>
    <investigator>
      <last_name>Petra Büchner-Steudel, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sebastian Krug</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nora Schweitzer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hamburg Onkologisch-Hämatologische Schwerpunktpraxis</name>
      <address>
        <city>Hamburg</city>
        <zip>22457</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Graefe</last_name>
    </contact>
    <contact_backup>
      <last_name>Mona Porep</last_name>
    </contact_backup>
    <investigator>
      <last_name>Tobias Graefe</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefan Bonmann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristine Hochgartz, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christine Lange-Hüsken</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sigrun Müller-Hagen, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Torsten Winterberg, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus Hamm</name>
      <address>
        <city>Hamm</city>
        <zip>59063</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Baraniskin, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Claudia Pospiech</last_name>
    </contact_backup>
    <investigator>
      <last_name>Alexander Baraniskin, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ruxandra Elena Parascan, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marina Dreglea</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Stoltefuß</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Anna Hospital Herne</name>
      <address>
        <city>Herne</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vera Heuer, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Monika Stache</last_name>
    </contact_backup>
    <investigator>
      <last_name>Vera Heuer, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christoph Dobrescu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tjorven K Förster</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philipp J Haubold</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Jazra, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Viktor Rempel, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ortenau Klinikum Lahr-Ettenheim</name>
      <address>
        <city>Lahr</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Charles Moulin, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Kerstin Riedel</last_name>
    </contact_backup>
    <investigator>
      <last_name>Jean-Charles Moulin, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oliver Delic, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Angela Nieder, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oliver Schmah, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ÜBAG - MVZ Dr. Vehling-Kaiser GmbH</name>
      <address>
        <city>Landshut</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Sohm, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Ana Hoffmann, Dr.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Michael Sohm, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ursula Vehling-Kaiser, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Florian Kaiser, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Franziskus Finsterwalder, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mike Haberkorn</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maximilian Müller, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Langen, Gemeinschaftspraxis für Hämatologie und Onkologie</name>
      <address>
        <city>Langen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Köhler, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Beate Jung</last_name>
    </contact_backup>
    <investigator>
      <last_name>Andreas Köhler, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roswitha Fuchs, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katharina Girod, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Studienzentrum UnterEms</name>
      <address>
        <city>Leer</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lothar Müller, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Christine Strohschnieder</last_name>
    </contact_backup>
    <investigator>
      <last_name>Lothar Müller, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Lippe</name>
      <address>
        <city>Lemgo</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Hartmann, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Melanie Kriete</last_name>
    </contact_backup>
    <investigator>
      <last_name>Frank Hartmann, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Constantin, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarunas Bagdonas, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Ludwigsburg</name>
      <address>
        <city>Ludwigsburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Angermeier, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Juliane Behn</last_name>
    </contact_backup>
    <investigator>
      <last_name>Stefan Angermeier, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthias Ulmer, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen und Marburg GmbH</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anja Rinke, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Erich Kort</last_name>
    </contact_backup>
    <investigator>
      <last_name>Anja Rinke, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Malte Zumblick, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sonja Gehring, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinik München-Bogenhausen</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Fuchs, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Bettina Huß</last_name>
    </contact_backup>
    <investigator>
      <last_name>Martin Fuchs, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Irene Klingenberg, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jael Nisenbaum, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fabian Hartmann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Münster, Gemeinschaftspraxis für Hämatologie und Onkologie</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rüdiger Liersch, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Martina Ester</last_name>
    </contact_backup>
    <investigator>
      <last_name>Rüdiger Liersch, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Lerchenüller, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ralf Bieker, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karsten Kratz-Albers, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Holger Timmer, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniela Schüler, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Niels-Stensen-Kliniken Osnabrück</name>
      <address>
        <city>Osnabrück</city>
        <zip>49074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kerstin Schütte, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Birgit Unterberg</last_name>
    </contact_backup>
    <investigator>
      <last_name>Kerstin Schütte, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristina Middelberg-Bisping, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medius Klinik Osterfildern-Ruit</name>
      <address>
        <city>Ostfildern</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bodo Klump, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Chistine Neumann</last_name>
    </contact_backup>
    <investigator>
      <last_name>Bodo Klump, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alberta-May Daraban-Brixner, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nikolai Schuelper, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karin Waibel, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brüder</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Moosmann, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Christiane Reinert</last_name>
    </contact_backup>
    <investigator>
      <last_name>Nicolas Moosmann, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anke Schlenska-Lange, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nadia Maguire, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>V. Berberich, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jan Braess, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Susanne Thalmeier, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heribert Stauder, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Schenk, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernhard Heilmeier, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernard Braun, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Rheine, Mathias-Spital Rheine</name>
      <address>
        <city>Rheine</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastian Broeckling, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Kerstin Vehring</last_name>
    </contact_backup>
    <investigator>
      <last_name>Sebastian Broeckling, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefan Zicholl, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonia Hansmeier, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guido Bisping, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>RoMed Klinikum Rosenheim</name>
      <address>
        <city>Rosenheim</city>
        <zip>83022</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gerhard Puchtler, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Senada Herrmann</last_name>
    </contact_backup>
    <investigator>
      <last_name>Gerhard Puchtler, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ulrike Kolar-Michaelis, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Südstadt Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beate Krammer-Steiner, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Dèsirèe Pürschel</last_name>
    </contact_backup>
    <investigator>
      <last_name>Beate Krammer-Steiner, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kerstin Peters, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sora Schipper, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henrike Broer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CaritasKlinikum Saarbrücken</name>
      <address>
        <city>Saarbrücken</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manfred Lutz, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Ulrike Schilling</last_name>
    </contact_backup>
    <investigator>
      <last_name>Manfred Lutz, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Clemens, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anca A Cura, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jérôme Schwingel</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Onkologie Bodensee</name>
      <address>
        <city>Singen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Fietz, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Karin Kingerter</last_name>
    </contact_backup>
    <investigator>
      <last_name>Thomas Fietz, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Hertkorn, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Niels Steinebrunner, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65199</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wolfgang Blau, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Sibylle Kerth-Krick</last_name>
    </contact_backup>
    <investigator>
      <last_name>Wolfgang Blau, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Natalia Heinz, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Moritz Lesse, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marien Hospital Witten</name>
      <address>
        <city>Witten</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Zeth, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Katja Fritz</last_name>
    </contact_backup>
    <investigator>
      <last_name>Matthias Zeth, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Metin Senkal, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Wolfsburg</name>
      <address>
        <city>Wolfsburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nils Homann, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Jeannette Wertmann</last_name>
    </contact_backup>
    <investigator>
      <last_name>Nils Homann, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steffen Neumann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Janine Markgraf</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexander Behrens, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ulrike Weber</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH</name>
      <address>
        <city>Wolfsburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Gabrysiak, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Carina Kupke</last_name>
    </contact_backup>
    <investigator>
      <last_name>Thomas Gabrysiak, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joachim Haessner, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katrin Heine, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jens Kersten</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://platon-network.de/</url>
    <description>The PLATON Network</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>Individualized cancer therapy</keyword>
  <keyword>Targetable mutations</keyword>
  <keyword>Foundation Medicine assays</keyword>
  <keyword>Hepatocellular Cancer</keyword>
  <keyword>Cholangiocarcinoma</keyword>
  <keyword>Gallbladder Cancer</keyword>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Oesophageal Cancer</keyword>
  <keyword>Stomach Cancer</keyword>
  <keyword>Platform-Design</keyword>
  <keyword>Biobanking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Gallbladder Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Depending on particpant informed concent individual-participant data (IPD) will only be shared in research-cooperations according the terms of PLATON's Use and Access Regulation. Scientific projects have to be approved by PLATON'S Scientific Steering Committee.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484636
org study id: PLATON pilot-study
secondary id: AIO-HEP/STO-0219/ass
nct id: NCT04484636
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
PLATON (Platform for Analyzing Targetable Mutations) is a prospective, multicentre,
      observational cohort study with biobanking. In a first approach PLATON's pilot-study assesses
      genomic profiling in gastrointestinal cancer therapy and the frequencies of targetable
      mutations including Tumor Mutational Burden (TMB) and Microsatellite Instability Status
      (MSI), performing Next-generation deep sequencing (NGS) using the Foundation Medicine assays
      on tumor specimen and EDTA-whole blood samples. The Study Protocol does not define any
      further medical intervention or evaluate the efficacy or safety of the treatment decision
      made by the investigator. Another important objective of PLATON's pilot project is to
      evaluate whether and how many patients are treated based on their genomic profiles.
PLATON (Platform for Analyzing Targetable Mutations) is designed to improve personalized
      therapy for patients in different cancer entities, such as in hepatocellular cancer (HCC),
      intra- and extrahepatic cholangiocellular carcinoma (CCA), gallbladder carcinoma (GBCA),
      pancreatic cancer (PanCa) and esophagogastric cancer (EC/GC), and elevate the treatment
      guidance within its framework. The key to understand the mechanisms in initiation,
      progression and response to treatment of cancer is the data integration of genetic mutational
      signatures with medical and physiological data of diseased cohorts.

      PLATON is a prospective, multicentre, observational cohort study with biobanking and does not
      define any medical intervention or evaluate the efficacy or safety of the treatment decision
      made by the investigator.In a first approach PLATON's pilot-study assess genomic profiling in
      gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor
      Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing
      Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen
      and EDTA-whole blood samples. Another important objective of PLATON's pilot project is to
      evaluate whether and how many patients are treated based on their genomic profiles.

      The pilot-study starts with the national-wide enrolment of 200 participants of both sexes and
      ages over 18 at 40 german study sites. The long-term vision is to enable cancer patients to
      receive the best available, scientifically founded, biomarker-based care, tailored to his or
      her individual needs
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Experimental Study
primary purpose: Other
masking: None (Open Label)
measure: Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer
time frame: up to 4 weeks after biospecimen provision
description: Relative frequency of targetable mutations (incl. TMB and MSI status) computed as the number of patients who harbors at least one mutation divided by the number of total patients in the pooled patient population.
measure: Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA
time frame: up to 4 weeks after biospecimen provision
description: Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA
measure: Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group
time frame: up to 4 weeks after biospecimen provision
description: Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group
measure: Number of patients receiving therapies in accordance to their genomic profiles
time frame: up to 4 weeks after biospecimen provision
description: Number of patients receiving therapies in accordance to their genomic profiles
arm group label: Hepatocellular Cancer
arm group type: Other
description: molecular profiling - hepatocellular cancer (HCC)
arm group label: Cholangiocarcinoma
arm group type: Other
description: molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)
arm group label: Gallbladder Cancer
arm group type: Other
description: molecular profiling - gallbladder carcinoma (GBCA)
arm group label: Pancreatic Cancer
arm group type: Other
description: molecular profiling - pancreatic cancer (PanCa)
arm group label: Oesophageal Cancer + Stomach Cancer
arm group type: Other
description: molecular profiling - esophagogastric cancer (EC/GC)
intervention type: Diagnostic Test
intervention name: FoundationOne®CDx and FoundationOne®Liquid
description: FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
arm group label: Cholangiocarcinoma
arm group label: Gallbladder Cancer
arm group label: Hepatocellular Cancer
arm group label: Oesophageal Cancer + Stomach Cancer
arm group label: Pancreatic Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salah-Eddin Al-Batran, Prof.
role: Study Director
affiliation: Institut für Klinische Krebsforschung IKF GmbH
last name: Arndt Vogel, Prof.
role: Principal Investigator
affiliation: Hannover Medical School
last name: Arndt Vogel, Prof. Dr.
phone: +4969-7601-4420
email: vogela@me.com
last name: Bianca Zäpf
phone: +4969-7601-4636
email: zaepf.bianca@ikf-khnw.de
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country: Germany
url: https://platon-network.de/
description: The PLATON Network
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Cholangiocarcinoma
mesh term: Gallbladder Neoplasms
mesh term: Stomach Neoplasms
mesh term: Liver Neoplasms
mesh term: Carcinoma, Hepatocellular
sharing ipd: No
ipd description: Depending on particpant informed concent individual-participant data (IPD) will only be shared in research-cooperations according the terms of PLATON's Use and Access Regulation. Scientific projects have to be approved by PLATON'S Scientific Steering Committee.