Study Stopped
Sponsor Decision
Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
1 other identifier
observational
51
1 country
20
Brief Summary
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
October 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2019
CompletedApril 14, 2020
April 1, 2020
1 year
September 24, 2018
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of subjects with discordant results that can be attributed to intercurrent disease
A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview.
3 years after positive Cologuard result
Study Arms (4)
Baseline Cologuard positive and negative colonoscopy
Those whose Cologuard T0 result was positive and colonoscopy result was negative.
Baseline Cologuard positive and no colonoscopy
Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.
3-year follow-up Cologuard positive and negative colonoscopy
Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative.
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.
Interventions
Observational
Eligibility Criteria
There are four sub-populations of the Cologuard Post-Approval Study (2014-01) under observation: positive first Cologuard test and negative colonoscopy or no colonoscopy and positive 3-year follow-up Cologuard test and negative colonoscopy or no colonoscopy.
You may qualify if:
- Subject falls into one of the 4 sub-populations
- Willing to provide informed consent
You may not qualify if:
- Death
- Investigator/sponsor decision
- Subject withdrew consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Thomas C Lenzmeier, M.D., P.C.
Glendale, Arizona, 85308, United States
Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Fiel Family and Sports Medicine, PC
Tempe, Arizona, 85206, United States
Cassidy Medical Group
Carlsbad, California, 92008, United States
John D. Homan, MD
Newport Beach, California, 92663, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Homestead Medical Research
Homestead, Florida, 33030, United States
Health Awareness Inc., Jupiter
Jupiter, Florida, 33458, United States
Health Awareness Inc., Port St. Lucie
Port Saint Lucie, Florida, 34984, United States
The Kaufmann Clinic
Atlanta, Georgia, 30308, United States
Indiana University, Eskanazi Hospital, Regenstrief Health Center
Indianapolis, Indiana, 46202, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Nevada Family Care
Henderson, Nevada, 89074, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Family Practice Center of Wooster
Massillon, Ohio, 44647, United States
Austin Regional Clinic
Austin, Texas, 78759, United States
PCP for Life
Montgomery, Texas, 77356, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2018
First Posted
October 15, 2018
Study Start
October 30, 2018
Primary Completion
November 16, 2019
Study Completion
November 16, 2019
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share