<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/NCT03789162</url>
  </required_header>
  <id_info>
    <org_study_id>2018-07</org_study_id>
    <nct_id>NCT03789162</nct_id>
  </id_info>
  <brief_title>Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast</brief_title>
  <official_title>Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast</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>
    <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 study is to collect de-identified, clinically-characterized&#xD;
      stool and whole blood specimens for use in developing and evaluating the performance of new&#xD;
      biomarker assays for the detection of colorectal cancer (CRC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be men and women, 40 years of age or older, with a diagnosis of CRC, at any&#xD;
      stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious&#xD;
      for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>Stool-based biomarkers associated with genetic and epigenetic alterations</measure>
    <time_frame>Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure</time_frame>
    <description>The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood-based biomarkers associated with genetic and epigenetic alterations</measure>
    <time_frame>Point in time blood collection (1 day) at enrollment</time_frame>
    <description>The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Confirmed CRC with Residual Lesion</arm_group_label>
    <description>A diagnosis of CRC confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Residual blood and stool samples may be used for evaluating the performance of biomarkers for&#xD;
      feasibility and assay development. Samples may be stored for up to 20 years. These blood and&#xD;
      stool samples will be de-identified.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 750 subjects will be enrolled. Subjects will be men and women, 40 years of&#xD;
        age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a&#xD;
        colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated&#xD;
        adenoma) or CRC on a pre-enrollment colonoscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is male or female, 40 years of age or older.&#xD;
&#xD;
          2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a&#xD;
             colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile&#xD;
             serrated adenoma) or CRC on a pre-enrollment colonoscopy.&#xD;
&#xD;
          3. Post-colonoscopy, the residual lesion in the colon must be at least 1 cm in size as to&#xD;
             require additional surgical excision or complex colonoscopic polypectomy.&#xD;
&#xD;
          4. Subject understands the study procedures and is able to provide informed consent to&#xD;
             participate in the study and authorization for release of relevant protected health&#xD;
             information to the study Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin&#xD;
             cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation,&#xD;
             and/or surgery) within the past 5 years.&#xD;
&#xD;
          2. Less than 7 days between colonoscopy and blood and stool sample collection.&#xD;
&#xD;
          3. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool&#xD;
             collection.&#xD;
&#xD;
          4. Subject has any condition that in the opinion of the Investigator should preclude&#xD;
             participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amber Cheng</last_name>
    <phone>608.982.1588</phone>
    <email>acheng@exactsciences.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic - Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Alliance Research Institute</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Omo Imaku</last_name>
      <phone>951-283-3402</phone>
      <email>omoimaku@allianceri.org</email>
    </contact>
    <investigator>
      <last_name>Saleem Desai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alliance Research Center</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research, LLC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Fairfield County, P.C.</name>
      <address>
        <city>Fairfield</city>
        <state>Connecticut</state>
        <zip>06824</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Institute</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cecile Guttermuth</last_name>
      <phone>860-585-3838</phone>
      <email>cguttermuth@connecticutgi.org</email>
    </contact>
    <investigator>
      <last_name>Salam Zakko</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Cortezzo</last_name>
    </contact>
    <investigator>
      <last_name>Xavier Llor, Md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guardian Angel Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research/Southwest Gastroenterology</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ranjit Singh</last_name>
      <phone>281-517-0550</phone>
      <email>ranjit@dmclinicalresearch.com</email>
    </contact>
    <investigator>
      <last_name>Charles Berkelhammer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital dba Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic, Inc.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic, Inc</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>MZS Research, LLC</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Delta Research Partners</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa McCullars, RN, CCRC</last_name>
      <phone>318-807-0819</phone>
      <email>mmccullars@gastromds.com</email>
    </contact>
    <investigator>
      <last_name>Bal Raj Bhandari</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Center, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beverly Carroll</last_name>
      <phone>318-525-3227</phone>
    </contact>
    <investigator>
      <last_name>Humberto I Aguilar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America, LLC</name>
      <address>
        <city>West Monroe</city>
        <state>Louisiana</state>
        <zip>71291</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Capitol Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Commonwealth Clinical Studies</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02302</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research, LLC</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>HealthPartners Institute</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Oncology Research</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Virtua Health Inc</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Health Service Hospitals, Inc.</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathy Hughes</last_name>
      <phone>607-763-5368</phone>
    </contact>
    <investigator>
      <last_name>Leslie Bank, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Care, PC</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai Beth Israel</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Digestive Health Partners, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Charlotte Gastroenterology &amp; Hepatology, PLLC</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beth Martinotti, CCRC</last_name>
      <phone>704-602-6564</phone>
      <email>beth.martinotti@charlottegastro.com</email>
    </contact>
    <investigator>
      <last_name>Jason Wilson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America, LLC</name>
      <address>
        <city>Mount Airy</city>
        <state>North Carolina</state>
        <zip>27030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Trial Management Associates, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research, LLC</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Great Lakes Gastroenterology Research, LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>TJ Lockhart</last_name>
      <phone>440-205-1225</phone>
      <phone_ext>212</phone_ext>
      <email>tlockhart@glmrx.com</email>
    </contact>
    <investigator>
      <last_name>Don Brinberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research, LLC</name>
      <address>
        <city>Westlake</city>
        <state>Ohio</state>
        <zip>44145</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Susquehanna Research Group</name>
      <address>
        <city>Camp Hill</city>
        <state>Pennsylvania</state>
        <zip>17011</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Balay</last_name>
      <phone>717-914-7770</phone>
      <email>jbalay@gicare.com</email>
    </contact>
    <investigator>
      <last_name>Lindsey Surace</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Presque Isle Colon and Rectal Surgery, an affiliate of The Clinical Trials Network, LLC</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Frontier Clinical Research, LLC</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerie Fornili</last_name>
      <phone>608-848-8900</phone>
      <email>vfornili@frontierclinical.com</email>
    </contact>
    <investigator>
      <last_name>Frederick Ruthardt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gastro One</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic Professional Association</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research, LLC</name>
      <address>
        <city>Union City</city>
        <state>Tennessee</state>
        <zip>38261</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LaMonica Connell</last_name>
    </contact>
    <investigator>
      <last_name>Kofi Nuako, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northside Gastroenterology Associates PA</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Digestive Health</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shatabdi Satpathi</last_name>
      <phone>949-491-0710</phone>
      <email>shatabdi@aceclinicalresearch.com</email>
    </contact>
    <investigator>
      <last_name>G. S. Ramesh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ilimbek Beketaev Beketaev</last_name>
      <phone>713-500-5232</phone>
      <email>Ilimbek.Beketaev@uth.tmc.edu</email>
    </contact>
    <investigator>
      <last_name>Hani Zamil</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texarkana Clinical Research</name>
      <address>
        <city>Texarkana</city>
        <state>Texas</state>
        <zip>75503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Medical Research</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Wilson</last_name>
      <phone>434-455-8659</phone>
      <email>heather.wilson@gastrocentralva.com</email>
    </contact>
    <investigator>
      <last_name>Larry E Clark Jr., MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Gastroenterology Institute</name>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23434</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Crawford</last_name>
      <phone>757-942-2566</phone>
      <email>wcrawford@virginiagastro.com</email>
    </contact>
    <investigator>
      <last_name>Pramod Malik, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research &amp; Innovation - Tacoma</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>HSHS St. Vincent Hospital Regional Cancer Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Clagary, Forzani &amp; MacPhail Colon Cancer Screening Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Draw</keyword>
  <keyword>Sample Collection</keyword>
  <keyword>Stool DNA</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>No</sharing_ipd>
  </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/NCT03789162
org study id: 2018-07
nct id: NCT03789162
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to collect de-identified, clinically-characterized
      stool and whole blood specimens for use in developing and evaluating the performance of new
      biomarker assays for the detection of colorectal cancer (CRC).
Subjects will be men and women, 40 years of age or older, with a diagnosis of CRC, at any
      stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious
      for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.
observational model: Cohort
time perspective: Prospective
measure: Stool-based biomarkers associated with genetic and epigenetic alterations
time frame: Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure
description: The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.
measure: Blood-based biomarkers associated with genetic and epigenetic alterations
time frame: Point in time blood collection (1 day) at enrollment
description: The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.
arm group label: Confirmed CRC with Residual Lesion
description: A diagnosis of CRC confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.
Residual blood and stool samples may be used for evaluating the performance of biomarkers for
      feasibility and assay development. Samples may be stored for up to 20 years. These blood and
      stool samples will be de-identified.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Amber Cheng
phone: 608.982.1588
email: acheng@exactsciences.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Terminated
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No