<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/NCT01723969</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-40CRC</org_study_id>
    <secondary_id>2012-003714-14</secondary_id>
    <nct_id>NCT01723969</nct_id>
  </id_info>
  <brief_title>Screening Platform for Clinical Trials in Advanced Colorectal Cancer</brief_title>
  <acronym>SPECTAcolor</acronym>
  <official_title>Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer &quot;SPECTAcolor&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a&#xD;
      European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this&#xD;
      screening platform is to provide quick access to new drugs to patients by offering a new&#xD;
      structure for clinical trials.&#xD;
&#xD;
      Currently some of the most challenging clinical questions arise from the molecular&#xD;
      sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways&#xD;
      in the patients.&#xD;
&#xD;
      A major problem for trials in this &quot;personalized medicine&quot; is that the low frequency of the&#xD;
      different mutations requires a high effort for screening and identifying the patients.&#xD;
&#xD;
      The EORTC CRC screening platform will hopefully offer a feasible and efficient way to&#xD;
      characterize the patients on the molecular basis of their tumors and allow to offer them&#xD;
      rapid and preferential participation in clinical studies with new drugs targeted to their&#xD;
      specific pathway alterations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tumour markers assessment</measure>
    <time_frame>Within 1 week after patient registration</time_frame>
    <description>Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">668</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Advanced Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Colo-rectal cancer</arm_group_label>
    <description>Tumour markers testing in patients with advanced or metastatic colo-rectal cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Tumour markers testing</intervention_name>
    <description>Tumour markers testing in patients advanced or metastatic colo-rectal cancer.</description>
    <arm_group_label>Colo-rectal cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      FFPE blocks of tumour tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced or metastatic colo-rectal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colo-rectal cancer (advanced or metastatic)&#xD;
&#xD;
          -  Before patient registration, written informed consent must be given according to&#xD;
             ICH/GCP, and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of patient's consent&#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>Gunnar Folprecht, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitaetsklinikum Carl Gustav Carus, Dresden, DE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabine Tejpar, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>U.Z. Leuven - Campus Gasthuisberg, Leuven, BE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniela Aust, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitaetsklinikum Carl Gustav Carus, Dresden, DE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.Z. Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bank Of Cyprus Oncology Centre</name>
      <address>
        <city>Stróvolos</city>
        <zip>2006</zip>
        <country>Cyprus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy Cancer Campus</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>DE 01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaets-Krankenhaus Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>DE 04205</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern</name>
      <address>
        <city>Muenchen</city>
        <zip>DE 81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Oldenburg</name>
      <address>
        <city>Oldenburg</city>
        <zip>DE 26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital Heraklion</name>
      <address>
        <city>Heraklion</city>
        <zip>GR 71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliera Universitaria San Martino &quot;IST&quot; Istituto Nazionale per la Ricerca sul Cancro</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seconda Universita Degli Studi Di Napoli</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Great Poland Cancer Centre</name>
      <address>
        <city>Poznan</city>
        <zip>PL 61 866</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maria Sklodowska-Curie Memorial Cancer Centre</name>
      <address>
        <city>Warsaw</city>
        <zip>PL 02 781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.P.O. Francisco Gentil - Centro De Lisboa</name>
      <address>
        <city>Lisboa</city>
        <zip>PT 1099-023</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>ES 08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <zip>ES 08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>ES 28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 De Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>ES 28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ostra Sjukhuset</name>
      <address>
        <city>Goteborg</city>
        <zip>SE 41685</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie</name>
      <address>
        <city>Geneva</city>
        <zip>CH-1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <zip>CH-1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital du Valais - Hopital de Sion</name>
      <address>
        <city>Sion</city>
        <zip>CH 1951</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>CH 8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Cyprus</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>July 1, 2022</last_update_submitted>
  <last_update_submitted_qc>July 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 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>Colorectal 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/NCT01723969
org study id: EORTC-40CRC
secondary id: 2012-003714-14
nct id: NCT01723969
lead sponsor: 
has dmc: Yes
The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a
      European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this
      screening platform is to provide quick access to new drugs to patients by offering a new
      structure for clinical trials.

      Currently some of the most challenging clinical questions arise from the molecular
      sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways
      in the patients.

      A major problem for trials in this "personalized medicine" is that the low frequency of the
      different mutations requires a high effort for screening and identifying the patients.

      The EORTC CRC screening platform will hopefully offer a feasible and efficient way to
      characterize the patients on the molecular basis of their tumors and allow to offer them
      rapid and preferential participation in clinical studies with new drugs targeted to their
      specific pathway alterations.
observational model: Case-Only
time perspective: Prospective
measure: Tumour markers assessment
time frame: Within 1 week after patient registration
description: Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
arm group label: Colo-rectal cancer
description: Tumour markers testing in patients with advanced or metastatic colo-rectal cancer
intervention type: Genetic
intervention name: Tumour markers testing
description: Tumour markers testing in patients advanced or metastatic colo-rectal cancer.
arm group label: Colo-rectal cancer
FFPE blocks of tumour tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gunnar Folprecht, MD
role: Study Chair
affiliation: Universitaetsklinikum Carl Gustav Carus, Dresden, DE
last name: Sabine Tejpar, MD, PhD
role: Study Chair
affiliation: U.Z. Leuven - Campus Gasthuisberg, Leuven, BE
last name: Daniela Aust, MD
role: Study Chair
affiliation: Universitaetsklinikum Carl Gustav Carus, Dresden, DE
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country: Belgium
country: Cyprus
country: France
country: Germany
country: Greece
country: Italy
country: Poland
country: Portugal
country: Spain
country: Sweden
country: Switzerland
responsible party type: Sponsor
mesh term: Colorectal Neoplasms