Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
- Conditions
- Colorectal Cancer
- Registration Number
- NCT03821948
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5131
- 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.
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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.
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Subject has a diagnosis or personal history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- 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.
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Subject has a family history of:
- Familial adenomatous polyposis (also referred to as "FAP").
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
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Subjects with Cronkhite-Canada Syndrome.
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IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
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Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool-based biomarkers associated with genetic and epigenetic alterations Stool sample will be collected prior to initiation of bowel preparation for colonoscopy. 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.
Blood-based biomarkers associated with genetic and epigenetic alterations. Point in time blood collection (1 day) at enrollment. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Marvel Research, LLC
🇺🇸Huntington Beach, California, United States
GW Research, Inc
🇺🇸Chula Vista, California, United States
Desert Medical Group Inc
🇺🇸Palm Springs, California, United States
Great Lakes Medical Research, LLC
🇺🇸Union City, Tennessee, United States
Margaret Mary Health
🇺🇸Batesville, Indiana, United States
Deaconess Clinic-Mt. Pleasant
🇺🇸Evansville, Indiana, United States
Deaconess Clinic-Gateway
🇺🇸Newburgh, Indiana, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Capitol Research
🇺🇸Rockville, Maryland, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Digestive Disease Care, PC
🇺🇸New Hyde Park, New York, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
🇺🇸Massillon, Ohio, United States
Comprehensive Internal Medicine, Inc
🇺🇸Wooster, Ohio, United States
MediSync Clinical Research
🇺🇸Austin, Texas, United States
Northside Gastroenterology
🇺🇸Cypress, Texas, United States
Charlotte Gastroenterology and Hepatology, LLC
🇺🇸Charlotte, North Carolina, United States
Great Lakes Medical Research
🇺🇸Erie, Pennsylvania, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Susquehanna Research Group
🇺🇸Harrisburg, Pennsylvania, United States
Virginia Gastroenterology Institute
🇺🇸Suffolk, Virginia, United States
DM Clinical Research/PCP For Life
🇺🇸Magnolia, Texas, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
Digestive Health Partners, PA
🇺🇸Asheville, North Carolina, United States
CCT Research/Fiel Family and Sports Medicine
🇺🇸Tempe, Arizona, United States
Connecticut Clinical Research Institute, LLC
🇺🇸Hartford, Connecticut, United States
DM Clinical Research/Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Digestive Health Associates
🇺🇸Houston, Texas, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Vilo Research Group, Inc
🇺🇸Houston, Texas, United States
Wenatchee Valley Hospital
🇺🇸Wenatchee, Washington, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Guardian Angel Research Center
🇺🇸Tampa, Florida, United States