<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/NCT03821948</url>
  </required_header>
  <id_info>
    <org_study_id>2018-08</org_study_id>
    <nct_id>NCT03821948</nct_id>
  </id_info>
  <brief_title>Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold</brief_title>
  <official_title>Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold</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>
    <is_us_export>No</is_us_export>
  </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 detection of colorectal cancer (CRC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy.&#xD;
      Approximately 7,500 subjects will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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 prior to initiation of bowel preparation for colonoscopy.</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 at average risk or increased risk for development of 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 at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5131</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Average CRC Risk Group</arm_group_label>
    <description>Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increased CRC Risk Group</arm_group_label>
    <description>Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Residual blood and stool samples may be used for evaluating performance of biomarkers for&#xD;
      feasibility and assay development. Sample 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>
        Subjects will be men and women, 40 years of age or older who are scheduled for a&#xD;
        colonoscopy. Approximately 7,500 subjects will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is male or female, 40 years of age or older.&#xD;
&#xD;
          -  Subject is at average or increased risk for development of CRC.&#xD;
&#xD;
          -  Subject presents for screening or surveillance colonoscopy.&#xD;
&#xD;
          -  Subject has no symptoms that require immediate, or near term, referral for diagnostic&#xD;
             or therapeutic colonoscopy.&#xD;
&#xD;
          -  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;
          -  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;
          -  Subject has a diagnosis or personal history of any of the following conditions,&#xD;
             including:&#xD;
&#xD;
               1. Familial adenomatous polyposis (also referred to as &quot;FAP&quot;, including attenuated&#xD;
                  FAP and Gardner's syndrome).&#xD;
&#xD;
               2. Hereditary non-polyposis CRC syndrome (also referred to as &quot;HNPCC&quot; or &quot;Lynch&#xD;
                  Syndrome&quot;).&#xD;
&#xD;
               3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers&#xD;
                  Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome,&#xD;
                  Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial&#xD;
                  Hyperplastic Polyposis.&#xD;
&#xD;
          -  Subject has a family history of:&#xD;
&#xD;
               1. Familial adenomatous polyposis (also referred to as &quot;FAP&quot;).&#xD;
&#xD;
               2. Hereditary non-polyposis CRC syndrome (also referred to as &quot;HNPCC&quot; or &quot;Lynch&#xD;
                  Syndrome&quot;).&#xD;
&#xD;
          -  Subjects with Cronkhite-Canada Syndrome.&#xD;
&#xD;
          -  IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.&#xD;
&#xD;
          -  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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CCT Research/Fiel Family and Sports Medicine</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GW Research, Inc</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marvel Research, LLC</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Medical Group Inc</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Institute, LLC</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Margaret Mary Health</name>
      <address>
        <city>Batesville</city>
        <state>Indiana</state>
        <zip>47006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic-Mt. Pleasant</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic-Gateway</name>
      <address>
        <city>Newburgh</city>
        <state>Indiana</state>
        <zip>47630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Research Institute</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Research Partners</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Group</name>
      <address>
        <city>Elkridge</city>
        <state>Maryland</state>
        <zip>21075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capitol Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AGA Clinical Research Associates, LLC</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Charlotte Gastroenterology and Hepatology, LLC</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Practice Center of Wooster, Inc./Clinical Trial Developers</name>
      <address>
        <city>Massillon</city>
        <state>Ohio</state>
        <zip>44647</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Comprehensive Internal Medicine, Inc</name>
      <address>
        <city>Wooster</city>
        <state>Ohio</state>
        <zip>44691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Susquehanna Research Group</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17110</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>MediSync Clinical Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Gastroenterology</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilo Research Group, Inc</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research/PCP For Life</name>
      <address>
        <city>Magnolia</city>
        <state>Texas</state>
        <zip>77355</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Virginia Gastroenterology Institute</name>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenatchee Valley Hospital</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</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>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 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 are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will 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/NCT03821948
org study id: 2018-08
nct id: NCT03821948
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: 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 detection of colorectal cancer (CRC).
Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy.
      Approximately 7,500 subjects will be enrolled.
observational model: Cohort
time perspective: Prospective
measure: Stool-based biomarkers associated with genetic and epigenetic alterations
time frame: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
description: The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of 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 at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
arm group label: Average CRC Risk Group
description: Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure
arm group label: Increased CRC Risk Group
description: Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure
Residual blood and stool samples may be used for evaluating performance of biomarkers for
      feasibility and assay development. Sample 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: Accepts Healthy Volunteers
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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 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 are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will available between 2 and 4 years after publication through the Sponsor.