<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/NCT04473625</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01B</org_study_id>
    <nct_id>NCT04473625</nct_id>
  </id_info>
  <brief_title>Stool Collection Sub-Study of Exact Sciences Protocol 2018-01</brief_title>
  <official_title>Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: &quot;Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exact Sciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exact Sciences Corporation</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>
      The primary objective of this sub-study is to obtain de-identified, clinically characterized,&#xD;
      stool specimens from subjects with untreated solid tumors for research use in the development&#xD;
      and validation of a stool-based test for colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">May 25, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</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>Stool-based test for colorectal cancer</measure>
    <time_frame>Point in time (one day) stool collection within 30 days of enrollment</time_frame>
    <description>Research for the development and validation of a stool-based test for colorectal cancer</description>
  </primary_outcome>
  <number_of_groups>12</number_of_groups>
  <enrollment type="Actual">291</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Colo-rectal Cancer</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Breast</arm_group_label>
    <description>Subjects with clinically confirmed breast cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lung</arm_group_label>
    <description>Subjects with clinically confirmed lung cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal</arm_group_label>
    <description>Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostate</arm_group_label>
    <description>Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bladder</arm_group_label>
    <description>Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uterine</arm_group_label>
    <description>Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kidney/Renal Pelvis</arm_group_label>
    <description>Subjects with clinically confirmed or suspicion of kidney/renal pelvis cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ovarian</arm_group_label>
    <description>Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver</arm_group_label>
    <description>Subjects with clinically confirmed liver cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreas</arm_group_label>
    <description>Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stomach</arm_group_label>
    <description>Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Esophageal</arm_group_label>
    <description>Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stool Sample Collection</intervention_name>
    <description>Subjects participating in the study will provide a stool sample within 30 days of enrollment.</description>
    <arm_group_label>Bladder</arm_group_label>
    <arm_group_label>Breast</arm_group_label>
    <arm_group_label>Colorectal</arm_group_label>
    <arm_group_label>Esophageal</arm_group_label>
    <arm_group_label>Kidney/Renal Pelvis</arm_group_label>
    <arm_group_label>Liver</arm_group_label>
    <arm_group_label>Lung</arm_group_label>
    <arm_group_label>Ovarian</arm_group_label>
    <arm_group_label>Pancreas</arm_group_label>
    <arm_group_label>Prostate</arm_group_label>
    <arm_group_label>Stomach</arm_group_label>
    <arm_group_label>Uterine</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool Collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be men and women, 18 years of age or older, who enroll in Exact Sciences&#xD;
        Protocol 2018-01. Approximately 450 subjects will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is currently enrolled in Exact Sciences Protocol 2018-01.&#xD;
&#xD;
          -  Subject is willing and able to provide a stool sample.&#xD;
&#xD;
          -  Subject understands the study procedures and is able to provide written informed&#xD;
             consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a condition the Investigator believes would interfere with his or her&#xD;
             ability to provide informed consent, comply with the sub-study protocol, or put the&#xD;
             person at undue risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Clinical Research Center, Inc.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Cancer Center</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CARTI Cancer Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Cancer Care</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Easter Ct Hematology</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSNF- Central Business Office</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Institute - Oncology Research</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Dominic's Gynecologic Oncology</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cone Health Cancer Center</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Cancer Trials of Utah</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAMC Clinical Trials Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Cologuard</keyword>
  <keyword>Sample Collection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.</ipd_time_frame>
    <ipd_access_criteria>Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.</ipd_access_criteria>
  </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/NCT04473625
org study id: 2018-01B
nct id: NCT04473625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this sub-study is to obtain de-identified, clinically characterized,
      stool specimens from subjects with untreated solid tumors for research use in the development
      and validation of a stool-based test for colorectal cancer.
observational model: Cohort
time perspective: Prospective
measure: Stool-based test for colorectal cancer
time frame: Point in time (one day) stool collection within 30 days of enrollment
description: Research for the development and validation of a stool-based test for colorectal cancer
arm group label: Breast
description: Subjects with clinically confirmed breast cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Lung
description: Subjects with clinically confirmed lung cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Colorectal
description: Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Prostate
description: Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Bladder
description: Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Uterine
description: Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Kidney/Renal Pelvis
description: Subjects with clinically confirmed or suspicion of kidney/renal pelvis cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Ovarian
description: Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Liver
description: Subjects with clinically confirmed liver cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Pancreas
description: Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Stomach
description: Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
arm group label: Esophageal
description: Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.
intervention type: Other
intervention name: Stool Sample Collection
description: Subjects participating in the study will provide a stool sample within 30 days of enrollment.
arm group label: Bladder
arm group label: Breast
arm group label: Colorectal
arm group label: Esophageal
arm group label: Kidney/Renal Pelvis
arm group label: Liver
arm group label: Lung
arm group label: Ovarian
arm group label: Pancreas
arm group label: Prostate
arm group label: Stomach
arm group label: Uterine
Stool Collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
ipd access criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.