<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/NCT03301493</url>
  </required_header>
  <id_info>
    <org_study_id>AGMT_NGS-Registry</org_study_id>
    <nct_id>NCT03301493</nct_id>
  </id_info>
  <brief_title>Genomic Testing and Resulting Medical Decisions</brief_title>
  <official_title>The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arbeitsgemeinschaft medikamentoese Tumortherapie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Arbeitsgemeinschaft medikamentoese Tumortherapie</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>
      There is no evidence available about which molecular profiling methods are currently used for&#xD;
      cancer patients in Austrian clinical practice. The construction of the registry proposed as a&#xD;
      completely independent research endeavor, will be helpful for scientific evaluation and the&#xD;
      establishment of highly credible data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the situation of enormous possible beneficial options for patients, health care systems,&#xD;
      researchers and companies and the simultaneously present high number of uncertainties, the&#xD;
      establishment of an independent registry for patients undergoing any type of comprehensive&#xD;
      genomic profiling offers many advantages.&#xD;
&#xD;
      In particular, an overview of the speed of development, the &quot;market penetration&quot;, the use of&#xD;
      the technology in specific indications (tumor types, stages and in specific situations of&#xD;
      unresponsiveness to certain drugs), the frequency by which treatment decisions will&#xD;
      definitely follow the result of comprehensive genomic profiling and the reasons for this, the&#xD;
      treatment outcome of such patients, the platform technologies applied (in-house (which&#xD;
      types), vs. commercial) and the development of these parameters over time and in relation to&#xD;
      the development of novel drugs will be analyzed.&#xD;
&#xD;
      The registry proposes to cover the time period from the years 2016 to 2019, which will allow&#xD;
      for assessment of both the current and emerging landscape of genomic/molecular testing&#xD;
      practice in Austria and effect of molecular profiling on patient care and outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Types of:molecular profiling methods</measure>
    <time_frame>3 years</time_frame>
    <description>To describe types of:molecular profiling methods used in the Austrian registry centres</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Types of cancer, for which comprehensive molecular profiling is used</measure>
    <time_frame>3 years</time_frame>
    <description>To describe types of cancer, for which comprehensive molecular profiling is used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timing of molecular profiling</measure>
    <time_frame>3 years</time_frame>
    <description>To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with mutations identified</measure>
    <time_frame>3 years</time_frame>
    <description>To describe targets identified:&#xD;
number of patients with at least one mutation identified&#xD;
number of patients with at least one druggable target identified&#xD;
number of patients with more than one druggable targets identified&#xD;
number of druggable targets per cancer type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality standards</measure>
    <time_frame>3 years</time_frame>
    <description>To describe tests used and quality standards:&#xD;
to compare results of NGS based molecular test systems with single marker tests or small gene panel tests&#xD;
quality standards of the test methods used (TAT, certification status)&#xD;
to evaluate development of methods used over time&#xD;
usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment decisions</measure>
    <time_frame>3 years</time_frame>
    <description>To describe treatment decisions:&#xD;
frequency by which treatment decision follows the result of NGS testing&#xD;
frequency with druggable targets with available on-label therapy option&#xD;
treatment decisions in the presence of more than one druggable target</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of treatment</measure>
    <time_frame>3 years</time_frame>
    <description>To describe outcome of treatment in patients receiving therapy in concordance with the test result</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cancer of Unknown Origin</condition>
  <condition>Cancer Refractory</condition>
  <condition>Cancer of Stomach</condition>
  <condition>Cancer Head Neck</condition>
  <condition>Cancer of Skin</condition>
  <condition>Cancer, Lung</condition>
  <condition>Cancer Colorectal</condition>
  <condition>Cancer of Esophagus</condition>
  <condition>Cancer, Bladder</condition>
  <condition>Cancer, Uterus</condition>
  <condition>Cancer Cervix</condition>
  <condition>Cancer Liver</condition>
  <condition>Cancer, Kidney</condition>
  <condition>Cancer, Breast</condition>
  <condition>Hematologic Neoplasms</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genomic testing</intervention_name>
    <description>Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort of oncology patients who received or plan to receive comprehensive genomic testing&#xD;
        anytime on or after January 1, 2016. Patient medical, testing and treatment information&#xD;
        will be obtained through extraction of data from existing patient medical charts.&#xD;
        Longitudinal follow-up data, including survival and tumor progression, will also be&#xD;
        extracted from patient medical charts. This patient follow-up data will be obtained until&#xD;
        patient death or loss to follow-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        This registry will include cancer patients for which broad genomic profiling is indicated&#xD;
        as assessed by the medical need and as deemed appropriate by the physician, for example&#xD;
&#xD;
          -  cancer with high mutational load and suspicion of regular or frequent formation of&#xD;
             neoantigens&#xD;
&#xD;
               -  skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head&#xD;
                  and neck, kidney, breast&#xD;
&#xD;
               -  lymphoma B-cell&#xD;
&#xD;
          -  any other neoplastic disease where molecular targeting is performed but treatment&#xD;
             fails&#xD;
&#xD;
          -  cancer of unknown primary origin (CUP)&#xD;
&#xD;
          -  planned or already carried out comprehensive genomic testing as of Jan 1, 2016 note:&#xD;
             this registry will not initially register patients who are tested for only 1-5&#xD;
             mutations by conventional means, but patients undergoing genomic profiling based on&#xD;
             NGS)&#xD;
&#xD;
          -  a patient´s signed informed consent&#xD;
&#xD;
          -  Patients ≥ 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Due to the non-interventional design of the registry there are no specific exclusion&#xD;
             criteria.&#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>Richard Greil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IIIrd Medical Department, Private Medical University Hospital Salzburg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard Greil, MD</last_name>
    <phone>+43577255</phone>
    <phone_ext>25801</phone_ext>
    <email>r.greil@salk.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Innere Medizin II, LKH Feldkirch</name>
      <address>
        <city>Feldkirch</city>
        <zip>6807</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Winder, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armin Gerger, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Seeber, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Krems</name>
      <address>
        <city>Krems an der Donau</city>
        <zip>6500</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Pecherstorfer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie</name>
      <address>
        <city>Linz</city>
        <zip>A-4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Petzer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IIIrd Medical Department, Private Medical University Hospital Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Greil, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum St. Pölten</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petra Pichler, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Salzkammergut-Klinikum Vöcklabruck</name>
      <address>
        <city>Vöcklabruck</city>
        <zip>4840</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klaus Wilthoner, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonja Heibl, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Singer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Vinzenz Krankenhaus Betriebs GmbH</name>
      <address>
        <city>Zams</city>
        <zip>6511</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edward Wöll, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Uterine Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03301493
org study id: AGMT_NGS-Registry
nct id: NCT03301493
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is no evidence available about which molecular profiling methods are currently used for
      cancer patients in Austrian clinical practice. The construction of the registry proposed as a
      completely independent research endeavor, will be helpful for scientific evaluation and the
      establishment of highly credible data.
In the situation of enormous possible beneficial options for patients, health care systems,
      researchers and companies and the simultaneously present high number of uncertainties, the
      establishment of an independent registry for patients undergoing any type of comprehensive
      genomic profiling offers many advantages.

      In particular, an overview of the speed of development, the "market penetration", the use of
      the technology in specific indications (tumor types, stages and in specific situations of
      unresponsiveness to certain drugs), the frequency by which treatment decisions will
      definitely follow the result of comprehensive genomic profiling and the reasons for this, the
      treatment outcome of such patients, the platform technologies applied (in-house (which
      types), vs. commercial) and the development of these parameters over time and in relation to
      the development of novel drugs will be analyzed.

      The registry proposes to cover the time period from the years 2016 to 2019, which will allow
      for assessment of both the current and emerging landscape of genomic/molecular testing
      practice in Austria and effect of molecular profiling on patient care and outcome.
observational model: Other
time perspective: Other
measure: Types of:molecular profiling methods
time frame: 3 years
description: To describe types of:molecular profiling methods used in the Austrian registry centres
measure: Types of cancer, for which comprehensive molecular profiling is used
time frame: 3 years
description: To describe types of cancer, for which comprehensive molecular profiling is used
measure: Timing of molecular profiling
time frame: 3 years
description: To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)
measure: Number of patients with mutations identified
time frame: 3 years
description: To describe targets identified:
number of patients with at least one mutation identified
number of patients with at least one druggable target identified
number of patients with more than one druggable targets identified
number of druggable targets per cancer type
measure: Quality standards
time frame: 3 years
description: To describe tests used and quality standards:
to compare results of NGS based molecular test systems with single marker tests or small gene panel tests
quality standards of the test methods used (TAT, certification status)
to evaluate development of methods used over time
usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)
measure: Treatment decisions
time frame: 3 years
description: To describe treatment decisions:
frequency by which treatment decision follows the result of NGS testing
frequency with druggable targets with available on-label therapy option
treatment decisions in the presence of more than one druggable target
measure: Outcome of treatment
time frame: 3 years
description: To describe outcome of treatment in patients receiving therapy in concordance with the test result
intervention type: Other
intervention name: Genomic testing
description: Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Greil, MD
role: Principal Investigator
affiliation: IIIrd Medical Department, Private Medical University Hospital Salzburg
last name: Richard Greil, MD
phone: +43577255
phone ext: 25801
email: r.greil@salk.at
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor
mesh term: Hematologic Neoplasms
mesh term: Breast Neoplasms
mesh term: Lung Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Stomach Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Skin Neoplasms
mesh term: Kidney Neoplasms
mesh term: Uterine Neoplasms