Spots Global Cancer Trial Database for Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
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Trial Identification
Brief Title: Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
Official Title: Observational Study of Sub-populations From "A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval"/Protocol 2014-01 Post-Approval Study
Study ID: NCT03705013
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Thomas C Lenzmeier, M.D., P.C., Glendale, Arizona, United States
Central Arizona Medical Associates, PC, Mesa, Arizona, United States
Fiel Family and Sports Medicine, PC, Tempe, Arizona, United States
Cassidy Medical Group, Carlsbad, California, United States
John D. Homan, MD, Newport Beach, California, United States
Desert Oasis Healthcare Medical Group, Palm Springs, California, United States
Innovative Research of West Florida, Clearwater, Florida, United States
Homestead Medical Research, Homestead, Florida, United States
Health Awareness Inc., Jupiter, Jupiter, Florida, United States
Health Awareness Inc., Port St. Lucie, Port Saint Lucie, Florida, United States
The Kaufmann Clinic, Atlanta, Georgia, United States
Indiana University, Eskanazi Hospital, Regenstrief Health Center, Indianapolis, Indiana, United States
Centennial Medical Group, Elkridge, Maryland, United States
Mayo Clinic, Rochester, Minnesota, United States
Nevada Family Care, Henderson, Nevada, United States
University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, United States
Family Practice Center of Wooster, Massillon, Ohio, United States
Austin Regional Clinic, Austin, Texas, United States
PCP for Life, Montgomery, Texas, United States
Wasatch Clinical Research, Salt Lake City, Utah, United States
Contact Details
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