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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
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 30, 2018
Primary Completion Date
November 16, 2019
Completion Date
November 16, 2019
Last Updated
April 14, 2020
51
ACTUAL participants
Cologuard
OTHER
Lead Sponsor
Exact Sciences Corporation
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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