Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
NCT ID: NCT03705013
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
51 participants
OBSERVATIONAL
2018-10-30
2019-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Baseline Cologuard positive and negative colonoscopy
Those whose Cologuard T0 result was positive and colonoscopy result was negative.
Cologuard
Observational
Baseline Cologuard positive and no colonoscopy
Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.
Cologuard
Observational
3-year follow-up Cologuard positive and negative colonoscopy
Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative.
Cologuard
Observational
3-year follow-up Cologuard positive and no colonoscopy
Those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol.
Cologuard
Observational
Interventions
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Cologuard
Observational
Eligibility Criteria
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Inclusion Criteria
* Willing to provide informed consent
Exclusion Criteria
* Investigator/sponsor decision
* Subject withdrew consent
50 Years
ALL
No
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2018-09
Identifier Type: -
Identifier Source: org_study_id
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