Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
NCT ID: NCT03821948
Last Updated: 2020-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5131 participants
OBSERVATIONAL
2019-01-03
2020-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
Yes
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Locations
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CCT Research/Fiel Family and Sports Medicine
Tempe, Arizona, United States
GW Research, Inc
Chula Vista, California, United States
Marvel Research, LLC
Huntington Beach, California, United States
Desert Medical Group Inc
Palm Springs, California, United States
Great Lakes Medical Research, LLC
San Diego, California, United States
Connecticut Clinical Research Institute, LLC
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Guardian Angel Research Center
Tampa, Florida, United States
DM Clinical Research/Southwest Gastroenterology
Oak Lawn, Illinois, 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
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
Capitol Research
Rockville, Maryland, United States
Great Lakes Medical Research, LLC
East Lansing, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
Digestive Disease Care, PC
New Hyde Park, New York, United States
Digestive Health Partners, PA
Asheville, North Carolina, United States
Charlotte Gastroenterology and Hepatology, LLC
Charlotte, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Great Lakes Medical Research
Beachwood, Ohio, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Massillon, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Great Lakes Medical Research, LLC
Westlake, Ohio, United States
Comprehensive Internal Medicine, Inc
Wooster, Ohio, United States
Great Lakes Medical Research
Erie, Pennsylvania, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
Great Lakes Medical Research, LLC
Union City, Tennessee, United States
MediSync Clinical Research
Austin, Texas, United States
Northside Gastroenterology
Cypress, Texas, United States
Vilo Research Group, Inc
Houston, Texas, United States
Digestive Health Associates
Houston, Texas, United States
DM Clinical Research/PCP For Life
Magnolia, Texas, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, United States
Wenatchee Valley Hospital
Wenatchee, Washington, United States
Countries
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Other Identifiers
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2018-08
Identifier Type: -
Identifier Source: org_study_id
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