Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5131

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • CCT Research/Fiel Family and Sports Medicine
  • California
    • Chula Vista, California, United States, 91910
      • GW Research, Inc
    • Huntington Beach, California, United States, 92647
      • Marvel Research, LLC
    • Palm Springs, California, United States, 92262
      • Desert Medical Group Inc
    • San Diego, California, United States, 92103
      • Great Lakes Medical Research, LLC
  • Connecticut
    • Hartford, Connecticut, United States, 06016
      • Connecticut Clinical Research Institute, LLC
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • DM Clinical Research/Southwest Gastroenterology
  • Indiana
    • Batesville, Indiana, United States, 47006
      • Margaret Mary Health
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinic-Mt. Pleasant
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic-Gateway
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • New Orleans Research Institute
    • Monroe, Louisiana, United States, 71201
      • Delta Research Partners
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
    • Rockville, Maryland, United States, 20850
      • Capitol Research
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Great Lakes Medical Research, LLC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
  • New York
    • New Hyde Park, New York, United States, 11040
      • Digestive Disease Care, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Digestive Health Partners, PA
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology and Hepatology, LLC
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates, LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Great Lakes Medical Research
    • Massillon, Ohio, United States, 44647
      • Family Practice Center of Wooster, Inc./Clinical Trial Developers
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
    • Westlake, Ohio, United States, 44145
      • Great Lakes Medical Research, LLC
    • Wooster, Ohio, United States, 44691
      • Comprehensive Internal Medicine, Inc
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Great Lakes Medical Research
    • Harrisburg, Pennsylvania, United States, 17110
      • Susquehanna Research Group
  • Tennessee
    • Union City, Tennessee, United States, 38261
      • Great Lakes Medical Research, LLC
  • Texas
    • Austin, Texas, United States, 78726
      • MediSync Clinical Research
    • Cypress, Texas, United States, 77429
      • Northside Gastroenterology
    • Houston, Texas, United States, 77017
      • Vilo Research Group, Inc
    • Houston, Texas, United States, 77024
      • Digestive Health Associates
    • Magnolia, Texas, United States, 77355
      • DM Clinical Research/PCP For Life
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
    • Suffolk, Virginia, United States, 23434
      • Virginia Gastroenterology Institute
  • Washington
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Subject is male or female, 40 years of age or older.
• Subject is at average or increased risk for development of CRC.
• Subject presents for screening or surveillance colonoscopy.
• Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

• Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.

• Subject has a diagnosis or personal history of any of the following conditions, including:

  1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.

• Subject has a family history of:

  1. Familial adenomatous polyposis (also referred to as "FAP").
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
• Subjects with Cronkhite-Canada Syndrome.
• IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
• Subject has any condition that in the opinion of the Investigator should preclude participation in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Average CRC Risk Group; 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
Increased CRC Risk Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool-based biomarkers associated with genetic and epigenetic alterations	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.	Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
Blood-based biomarkers associated with genetic and epigenetic alterations.	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.	Point in time blood collection (1 day) at enrollment.

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Sample Collection; Stool DNA; Blood Draw
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2018-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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 Sharing 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 Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No