Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
- Conditions
- Colorectal Cancer
- Interventions
- Other: Cologuard
- Registration Number
- NCT03705013
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
- Detailed Description
Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
- Subject falls into one of the 4 sub-populations
- Willing to provide informed consent
- Death
- Investigator/sponsor decision
- Subject withdrew consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 3-year follow-up Cologuard positive and negative colonoscopy Cologuard Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. 3-year follow-up Cologuard positive and no colonoscopy Cologuard Those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Baseline Cologuard positive and negative colonoscopy Cologuard Those whose Cologuard T0 result was positive and colonoscopy result was negative. Baseline Cologuard positive and no colonoscopy Cologuard Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.
- Primary Outcome Measures
Name Time Method The number of subjects with discordant results that can be attributed to intercurrent disease 3 years after positive Cologuard result A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
John D. Homan, MD
🇺🇸Newport Beach, California, United States
The Kaufmann Clinic
🇺🇸Atlanta, Georgia, United States
Health Awareness Inc., Port St. Lucie
🇺🇸Port Saint Lucie, Florida, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Nevada Family Care
🇺🇸Henderson, Nevada, United States
PCP for Life
🇺🇸Montgomery, Texas, United States
Health Awareness Inc., Jupiter
🇺🇸Jupiter, Florida, United States
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Family Practice Center of Wooster
🇺🇸Massillon, Ohio, United States
Thomas C Lenzmeier, M.D., P.C.
🇺🇸Glendale, Arizona, United States
Fiel Family and Sports Medicine, PC
🇺🇸Tempe, Arizona, United States
Central Arizona Medical Associates, PC
🇺🇸Mesa, Arizona, United States
Cassidy Medical Group
🇺🇸Carlsbad, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Homestead Medical Research
🇺🇸Homestead, Florida, United States
Indiana University, Eskanazi Hospital, Regenstrief Health Center
🇺🇸Indianapolis, Indiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Innovative Research of West Florida
🇺🇸Clearwater, Florida, United States