Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)

Exact Sciences Corporation

Status: Terminated

Conditions: Colorectal Cancer

Treatments: Other: Cologuard

Study type: Observational

Funder types: Industry

Identifiers

NCT03705013

2018-09

Details and patient eligibility

About

The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 4 patient groups

Baseline Cologuard positive and negative colonoscopy

Description:

Those whose Cologuard T0 result was positive and colonoscopy result was negative.

Treatment:

Other: Cologuard

Baseline Cologuard positive and no colonoscopy

Description:

Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.

Treatment:

Other: Cologuard

3-year follow-up Cologuard positive and negative colonoscopy

Description:

Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative.

Treatment:

Other: Cologuard

3-year follow-up Cologuard positive and no colonoscopy

Description:

Those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol.

Treatment:

Other: Cologuard