A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
1 other identifier
observational
2,404
1 country
40
Brief Summary
This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2020
CompletedApril 2, 2020
April 1, 2020
5 years
April 9, 2015
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive and Negative Predictive Value
The difference between the positive predictive value (PPV) at year 3 (PPV3) and 1 minus the negative predictive value (NPV) at year 3 (NPV3).
Three years
Secondary Outcomes (1)
Colorectal Cancer Incidence
3 years
Other Outcomes (13)
Predictive value of a positive Cologuard result at baseline (T0)
baseline
The predicative value of a positive and a negative Cologuard at year 3 (T3).
3 years
The sensitivity and specificity of Cologuard at year 3 (T3).
3 years
- +10 more other outcomes
Interventions
Prescription of Cologuard for at-home stool collection
Eligibility Criteria
The study will enroll approximately 2,400 men and women aged 50 years and older at a minimum of 20 sites to achieve a minimum of 1,119 subjects at the Year 3 visit. To increase the point prevalence of CRC in the study population, subject enrollment will be age-weighted toward a slightly older population. Enrollment of at least 65% of subjects age 65 years or older will be targeted
You may qualify if:
- Subject has been prescribed Cologuard for colorectal cancer screening
- Subject is at average risk for development of colorectal cancer
- Subject is 50 years or older
- Subject willing and able to sign informed consent.
You may not qualify if:
- Subject had a colonoscopy in the previous 9 years
- Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
- Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
- Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
- Subject has a history of colorectal cancer or advanced adenoma.
- Subject has a history of aerodigestive tract cancer
- Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
- Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
- Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
- One first-degree relative with CRC diagnosed before the age of 60.
- Subject has a family history of:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
- Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
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
Tempe, Arizona, 85283, United States
Cassidy Medical Group/Radiant Research, Inc.
Carlsbad, California, 92008, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Paragon Rx Clinical
Garden Grove, California, 92840, United States
UCLA, Division of Digestive Diseases
Los Angeles, California, 90095, United States
FACEY Medical Foundation
Mission Hills, California, 91345, United States
John D. Homan, MD
Newport Beach, California, 92663, United States
Diverse Research Solutions
Oxnard, California, 93030, United States
Ventura County Gastroenterology
Oxnard, California, 93030, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Advanced Pain Diagnostics & Solutions
Sacramento, California, 95825, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Homestead Medical Research
Homestead, Florida, 33030, United States
Health Awareness, Inc
Jupiter, Florida, 33458, United States
Precision Clinical Research
Lauderdale Lakes, Florida, 33319, United States
Advanced Bioresearch
Miami, Florida, 33134, United States
Next Phase Research Alliance
Miami, Florida, 33144, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Health Awareness, Inc-Port St. Lucie
Port Saint Lucie, Florida, 34984, United States
The Kaufmann Clinic, Inc.
Atlanta, Georgia, 30308, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Pharmakon Inc
Evergreen Park, Illinois, 60805, United States
Indiana University, Eskanazi Hospital, Regenstrief Health Center
Indianapolis, Indiana, 46202, United States
MedPharmics, LLC
Metairie, Louisiana, 70006, United States
Columbia Medical Practice
Columbia, Maryland, 21045, United States
Centennial Medical Associates
Elkridge, Maryland, 21075, United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
Nevada Family Care
Henderson, Nevada, 89074, United States
United Medical Associates
Binghamton, New York, 13901, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Sentral Clinical Research
Cincinnati, Ohio, 45236, United States
Comprehensive Internal Medicine, Inc.
Wooster, Ohio, 44691, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Wooster, Ohio, 45150, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438, United States
Austin Regional Clinic
Austin, Texas, 78759, United States
PCP for Life (DM Research)
Montgomery, Texas, 77356, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Biospecimen
A portion of the stool sample may be retained, if any remains after the study-related tests for use in a sample bank for use in the future. The samples may be stored for up to twenty (20) years. These stool samples will de-identified.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Imperiale, MD
Indiana University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 17, 2015
Study Start
April 1, 2015
Primary Completion
March 16, 2020
Study Completion
March 16, 2020
Last Updated
April 2, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.