Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.
- Conditions
- Colo-rectal Cancer
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03741166
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).
- Detailed Description
Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 871
- Subject is currently enrolled in Exact Sciences Protocol 2018-10
- Subject is willing and able to provide a blood sample.
- Subject is willing and able to sign informed consent.
- 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
- Arm && Interventions
Group Intervention Description Subject aged 45-49 with Average CRC Risk Blood Sample Collection Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Subjects will provide a blood sample at time of enrollment.
- Primary Outcome Measures
Name Time Method Blood-based biomarkers associated with genetic and epigenetic alterations. Point in time blood collection (1 day) at enrollment Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Northshore University Health System Evanston Hospital
🇺🇸Evanston, Illinois, United States
DM Clinical Research- Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Charlotte Gastroenterology & Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Commonwealth Clinical Studies
🇺🇸Brockton, Massachusetts, United States
Johnson County ClinTrials, LLC
🇺🇸Lenexa, Kansas, United States
New Orleans Research Institue
🇺🇸Metairie, Louisiana, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Ventura County Gastroenterology
🇺🇸Camarillo, California, United States
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
Deaconess Clinic- Mt. Pleasant
🇺🇸Evansville, Indiana, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Wilmington Gastroenterology Associates
🇺🇸Wilmington, North Carolina, United States
Gastroenterology Associates, PA
🇺🇸Greenville, South Carolina, United States
Focilmed
🇺🇸Oxnard, California, United States
Precision Clinical Research, LLC
🇺🇸Lauderdale Lakes, Florida, United States
Deaconess Clinic- Gateway
🇺🇸Newburgh, Indiana, United States
DM Clinical Research- PCP for Life
🇺🇸Houston, Texas, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Capitol Research
🇺🇸Rockville, Maryland, United States
University of Texas Health Science Center- McGovern Medical School
🇺🇸Houston, Texas, United States
Quality Medical Research, PLLC
🇺🇸Nashville, Tennessee, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
🇺🇸Wooster, Ohio, United States
Virginia Gastroenterology Institute
🇺🇸Suffolk, Virginia, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Yale University Section of Digestive Diseases and Liver Diseases
🇺🇸New Haven, Connecticut, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Comprehensive Internal Medicine, Inc.
🇺🇸Wooster, Ohio, United States