Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
1 other identifier
observational
5,131
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedFirst Submitted
Initial submission to the registry
January 16, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedJuly 21, 2020
July 1, 2020
1.2 years
January 16, 2019
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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:
- 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.
- 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").
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
CCT Research/Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
GW Research, Inc
Chula Vista, California, 91910, United States
Marvel Research, LLC
Huntington Beach, California, 92647, United States
Desert Medical Group Inc
Palm Springs, California, 92262, United States
Great Lakes Medical Research, LLC
San Diego, California, 92103, United States
Connecticut Clinical Research Institute, LLC
Hartford, Connecticut, 06016, United States
Yale University
New Haven, Connecticut, 06520, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
DM Clinical Research/Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Margaret Mary Health
Batesville, Indiana, 47006, United States
Deaconess Clinic-Mt. Pleasant
Evansville, Indiana, 47725, United States
Deaconess Clinic-Gateway
Newburgh, Indiana, 47630, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Capitol Research
Rockville, Maryland, 20850, United States
Great Lakes Medical Research, LLC
East Lansing, Michigan, 48823, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Digestive Disease Care, PC
New Hyde Park, New York, 11040, United States
Digestive Health Partners, PA
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterology and Hepatology, LLC
Charlotte, North Carolina, 28207, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Great Lakes Medical Research
Beachwood, Ohio, 44122, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Massillon, Ohio, 44647, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Great Lakes Medical Research, LLC
Westlake, Ohio, 44145, United States
Comprehensive Internal Medicine, Inc
Wooster, Ohio, 44691, United States
Great Lakes Medical Research
Erie, Pennsylvania, 16506, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110, United States
Great Lakes Medical Research, LLC
Union City, Tennessee, 38261, United States
MediSync Clinical Research
Austin, Texas, 78726, United States
Northside Gastroenterology
Cypress, Texas, 77429, United States
Vilo Research Group, Inc
Houston, Texas, 77017, United States
Digestive Health Associates
Houston, Texas, 77024, United States
DM Clinical Research/PCP For Life
Magnolia, Texas, 77355, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
Wenatchee Valley Hospital
Wenatchee, Washington, 98801, United States
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2019
First Posted
January 30, 2019
Study Start
January 3, 2019
Primary Completion
February 28, 2020
Study Completion
May 15, 2020
Last Updated
July 21, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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.
- 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.
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.