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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03705013
• Other study ID #: 2018-09
• Status: Terminated
• Start date: October 30, 2018
• Est. completion date: November 16, 2019

Study information

• Verified date: April 2020
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: November 16, 2019
• Est. primary completion date: November 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Cologuard
Observational

Locations

Country	Name	City	State
United States	The Kaufmann Clinic	Atlanta	Georgia
United States	Austin Regional Clinic	Austin	Texas
United States	Cassidy Medical Group	Carlsbad	California
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Centennial Medical Group	Elkridge	Maryland
United States	Thomas C Lenzmeier, M.D., P.C.	Glendale	Arizona
United States	Nevada Family Care	Henderson	Nevada
United States	Homestead Medical Research	Homestead	Florida
United States	Indiana University, Eskanazi Hospital, Regenstrief Health Center	Indianapolis	Indiana
United States	Health Awareness Inc., Jupiter	Jupiter	Florida
United States	Family Practice Center of Wooster	Massillon	Ohio
United States	Central Arizona Medical Associates, PC	Mesa	Arizona
United States	PCP for Life	Montgomery	Texas
United States	John D. Homan, MD	Newport Beach	California
United States	Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Health Awareness Inc., Port St. Lucie	Port Saint Lucie	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Fiel Family and Sports Medicine, PC	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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