<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/NCT03765736</url>
  </required_header>
  <id_info>
    <org_study_id>ACCRU-GI-1611</org_study_id>
    <secondary_id>NCI-2018-02862</secondary_id>
    <secondary_id>ACCRU-GI-1611</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT03765736</nct_id>
  </id_info>
  <brief_title>Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial</brief_title>
  <official_title>COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academic and Community Cancer Research United</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Academic and Community Cancer Research United</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial screens patients with colon or rectal cancer that has spread to other places in&#xD;
      the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations&#xD;
      for recommendation to a molecularly assigned therapy. Identifying gene mutations may help&#xD;
      patients enroll onto target companion trials that target these mutations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To perform blood-based genomic profiling on patients with treatment refractory metastatic&#xD;
      colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.&#xD;
&#xD;
      II. To facilitate clinically annotated genomic analyses.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients submit blood samples for genetic testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Anticipated">November 12, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 11, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients who have an actionable genomic profile</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Companion trial enrollment</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Metastatic Colon Adenocarcinoma</condition>
  <condition>Metastatic Rectal Adenocarcinoma</condition>
  <condition>Stage III Colon Cancer AJCC v8</condition>
  <condition>Stage III Rectal Cancer AJCC v8</condition>
  <condition>Stage IIIA Colon Cancer AJCC v8</condition>
  <condition>Stage IIIA Rectal Cancer AJCC v8</condition>
  <condition>Stage IIIB Colon Cancer AJCC v8</condition>
  <condition>Stage IIIB Rectal Cancer AJCC v8</condition>
  <condition>Stage IIIC Colon Cancer AJCC v8</condition>
  <condition>Stage IIIC Rectal Cancer AJCC v8</condition>
  <condition>Stage IV Colon Cancer AJCC v8</condition>
  <condition>Stage IV Rectal Cancer AJCC v8</condition>
  <condition>Stage IVA Colon Cancer AJCC v8</condition>
  <condition>Stage IVA Rectal Cancer AJCC v8</condition>
  <condition>Stage IVB Colon Cancer AJCC v8</condition>
  <condition>Stage IVB Rectal Cancer AJCC v8</condition>
  <condition>Stage IVC Colon Cancer AJCC v8</condition>
  <condition>Stage IVC Rectal Cancer AJCC v8</condition>
  <condition>Unresectable Colon Adenocarcinoma</condition>
  <condition>Unresectable Rectal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
    <description>Patients submit blood samples for genetic testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Testing</intervention_name>
    <description>Undergo genetic testing</description>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
    <other_name>genetic analysis</other_name>
    <other_name>Genetic Examination</other_name>
    <other_name>Genetic Test</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic&#xD;
             and/ or unresectable&#xD;
&#xD;
          -  Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5-&#xD;
             fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal&#xD;
             antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal&#xD;
             antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins&#xD;
             (dMMR) or is microsatellite instability-high (MSI-H)&#xD;
&#xD;
          -  For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or&#xD;
             contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)&#xD;
&#xD;
               -  Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor&#xD;
                  has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act&#xD;
                  (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required&#xD;
&#xD;
          -  At least one site of disease that is measurable by Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated;&#xD;
             if the patient has had previous radiation to the target lesion(s), there must be&#xD;
             evidence of progression since the radiation&#xD;
&#xD;
          -  Life expectancy &gt;= 3 months per estimation of investigator&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2&#xD;
&#xD;
          -  Capable of understanding and complying with the protocol requirements and has signed&#xD;
             the informed consent document&#xD;
&#xD;
          -  Satisfy at least one of the following two conditions:&#xD;
&#xD;
               -  Willing and able to provide blood sample for screening purposes&#xD;
&#xD;
               -  Guardant 360 testing completed =&lt; 60 days prior to registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence within the last 3 years of another malignancy which required systemic&#xD;
             treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or&#xD;
             localized prostate cancer with a current PSA of &lt; 1.0mg/dL on 2 successive&#xD;
             evaluations, at least 90 days apart, with the most recent evaluation no more than 4&#xD;
             weeks prior to registration&#xD;
&#xD;
          -  Unable or unwilling to abide by the study protocol or cooperate fully with the&#xD;
             investigator or designee&#xD;
&#xD;
          -  History of solid organ transplantation&#xD;
&#xD;
          -  Pregnant or planning to become pregnant within the next 12 months&#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>John H Strickler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academic and Community Cancer Research United</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referrals Office</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Tanios S. Bekaii-Saab</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ceonne Kim</last_name>
      <phone>858-822-0201</phone>
      <email>cek008@health.ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Shumei Kato</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rabia Rehman</last_name>
      <phone>323-865-0460</phone>
      <email>Rabia.Rehman@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>Heinz-Josef Lenz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Kearns</last_name>
      <phone>253-831-3423</phone>
      <email>Karen.Kearns@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Jun Gong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Violeta Milic</last_name>
      <phone>202-687-2353</phone>
      <email>Vm524@georgetown.edu</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Weinberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>RPS C. Intake Box</last_name>
      <email>FLARPSINTAKE@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Jeremy C. Jones</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Coleman</last_name>
      <phone>404-251-1275</phone>
      <email>kathleen.marie.coleman@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Olatunji Alese</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Intake Team</last_name>
      <phone>855-702-8222</phone>
      <email>cancerclinicaltrials@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel V. Catenacci</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GCC Nursing</last_name>
      <phone>617-632-3000</phone>
      <email>DFCIGCCRNRS@partners.org</email>
    </contact>
    <investigator>
      <last_name>Kimmie Ng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referrals Office</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Joleen M. Hubbard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>ACCRU Operations</last_name>
      <phone>507-538-7462</phone>
      <email>ACCRU@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Katrina S. Pedersen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Jackson</last_name>
      <phone>732-235-4024</phone>
      <email>jacsoka@cinj.rutgers.edu</email>
    </contact>
    <investigator>
      <last_name>Patrick M. Boland</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>ACCRU Operations</last_name>
      <phone>507-538-7457</phone>
      <email>ACCRU@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Andrea Cercek</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Amara</last_name>
      <phone>919-668-1861</phone>
      <email>Anthony.amara@duke.edu</email>
    </contact>
    <investigator>
      <last_name>John H. Strickler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Derzic</last_name>
      <phone>412-330-6263</phone>
      <email>Karen.derzic@ahn.org</email>
    </contact>
    <investigator>
      <last_name>Gene G. Finley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University/Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Intake Team</last_name>
      <phone>800-811-8480</phone>
    </contact>
    <investigator>
      <last_name>Kristen K. Ciombor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ngozi Nwokeji</last_name>
      <phone>713-792-2828</phone>
      <email>nfnwokeji@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Christine Parseghian</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Milwaukee</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milanka Petrovic</last_name>
      <email>Milanka.petrovic@aah.org</email>
    </contact>
    <investigator>
      <last_name>Antony Ruggeri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</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>Adenocarcinoma</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Colonic 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/NCT03765736
org study id: ACCRU-GI-1611
secondary id: NCI-2018-02862
secondary id: ACCRU-GI-1611
secondary id: P30CA015083
nct id: NCT03765736
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is us export: No
This trial screens patients with colon or rectal cancer that has spread to other places in
      the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations
      for recommendation to a molecularly assigned therapy. Identifying gene mutations may help
      patients enroll onto target companion trials that target these mutations.
PRIMARY OBJECTIVES:

      I. To perform blood-based genomic profiling on patients with treatment refractory metastatic
      colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.

      II. To facilitate clinically annotated genomic analyses.

      OUTLINE:

      Patients submit blood samples for genetic testing.
observational model: Cohort
time perspective: Prospective
measure: The proportion of patients who have an actionable genomic profile
time frame: Up to 5 years
description: This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
measure: Companion trial enrollment
time frame: Up to 5 years
description: This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
arm group label: Screening (genetic testing)
description: Patients submit blood samples for genetic testing.
intervention type: Other
intervention name: Genetic Testing
description: Undergo genetic testing
arm group label: Screening (genetic testing)
other name: genetic analysis
other name: Genetic Examination
other name: Genetic Test
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John H Strickler
role: Principal Investigator
affiliation: Academic and Community Cancer Research United
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Rectal Neoplasms
mesh term: Colonic Neoplasms