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

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

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

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Cologuard

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Thomas C Lenzmeier, M.D., P.C.
    • Mesa, Arizona, United States, 85206
      • Central Arizona Medical Associates, PC
    • Tempe, Arizona, United States, 85206
      • Fiel Family and Sports Medicine, PC
  • California
    • Carlsbad, California, United States, 92008
      • Cassidy Medical Group
    • Newport Beach, California, United States, 92663
      • John D. Homan, MD
    • Palm Springs, California, United States, 92262
      • Desert Oasis Healthcare Medical Group
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • Homestead, Florida, United States, 33030
      • Homestead Medical Research
    • Jupiter, Florida, United States, 33458
      • Health Awareness Inc., Jupiter
    • Port Saint Lucie, Florida, United States, 34984
      • Health Awareness Inc., Port St. Lucie
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • The Kaufmann Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University, Eskanazi Hospital, Regenstrief Health Center
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Nevada Family Care
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill
  • Ohio
    • Massillon, Ohio, United States, 44647
      • Family Practice Center of Wooster
  • Texas
    • Austin, Texas, United States, 78759
      • Austin Regional Clinic
    • Montgomery, Texas, United States, 77356
      • PCP for Life
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Baseline Cologuard positive and negative colonoscopy; Those whose Cologuard T0 result was positive and colonoscopy result was negative.	Other: Cologuard; Observational
Baseline Cologuard positive and no colonoscopy; Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.	Other: 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.	Other: 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.	Other: Cologuard; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): November 16, 2019
• Study Completion (Actual): November 16, 2019

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cologuard
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2018-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No