Clinical trial NCT03705013: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Keywords: Cologuard
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Subject falls into one of the 4 sub-populations
* Willing to provide informed consent

Exclusion Criteria:

* Death
* Investigator/sponsor decision
* Subject withdrew consent

Primary outcomes:
measure: The number of subjects with discordant results that can be attributed to intercurrent disease
timeFrame: 3 years after positive Cologuard result
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Thomas C Lenzmeier, M.D., P.C.
state: Arizona
city: Mesa
country: United States
facility: Central Arizona Medical Associates, PC
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC
state: Arizona
city: Carlsbad
country: United States
facility: Cassidy Medical Group
state: California
city: Newport Beach
country: United States
facility: John D. Homan, MD
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Homestead
country: United States
facility: Homestead Medical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness Inc., Jupiter
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness Inc., Port St. Lucie
state: Florida
city: Atlanta
country: United States
facility: The Kaufmann Clinic
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University, Eskanazi Hospital, Regenstrief Health Center
state: Indiana
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Henderson
country: United States
facility: Nevada Family Care
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Massillon
country: United States
facility: Family Practice Center of Wooster
state: Ohio
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Montgomery
country: United States
facility: PCP for Life
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
References: