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

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Cancer Screening
• Intervention / Treatment: Device: Cologuard

Detailed Description

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.

• Study Type: Observational
• Enrollment (Actual): 2404

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, 85283
      • Fiel Family and Sports Medicine
  • California
    • Carlsbad, California, United States, 92008
      • Cassidy Medical Group/Radiant Research, Inc.
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical
    • Los Angeles, California, United States, 90095
      • UCLA, Division of Digestive Diseases
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Newport Beach, California, United States, 92663
      • John D. Homan, MD
    • Oxnard, California, United States, 93030
      • Diverse Research Solutions
    • Oxnard, California, United States, 93030
      • Ventura County Gastroenterology
    • Palm Springs, California, United States, 92262
      • Desert Oasis Healthcare Medical Group
    • Sacramento, California, United States, 95825
      • Advanced Pain Diagnostics & Solutions
  • 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
    • Lauderdale Lakes, Florida, United States, 33319
      • Precision Clinical Research
    • Miami, Florida, United States, 33144
      • Next Phase Research Alliance
    • Miami, Florida, United States, 33134
      • Advanced Bioresearch
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
    • Port Saint Lucie, Florida, United States, 34984
      • Health Awareness, Inc-Port St. Lucie
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • The Kaufmann Clinic, Inc.
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Evergreen Park, Illinois, United States, 60805
      • Pharmakon Inc
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University, Eskanazi Hospital, Regenstrief Health Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Columbia Medical Practice
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Associates
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Nevada Family Care
  • New York
    • Binghamton, New York, United States, 13901
      • United Medical Associates
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Inc.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Sentral Clinical Research
    • Wooster, Ohio, United States, 44691
      • Comprehensive Internal Medicine, Inc.
    • Wooster, Ohio, United States, 45150
      • Family Practice Center of Wooster, Inc./Clinical Trial Developers
  • Pennsylvania
    • Harleysville, Pennsylvania, United States, 19438
      • Harleysville Medical Associates
  • Texas
    • Austin, Texas, United States, 78759
      • Austin Regional Clinic
    • Montgomery, Texas, United States, 77356
      • PCP for Life (DM Research)
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Subject has been prescribed Cologuard for colorectal cancer screening
2. Subject is at average risk for development of colorectal cancer
3. Subject is 50 years or older
4. Subject willing and able to sign informed consent.

Exclusion Criteria:

1. Subject had a colonoscopy in the previous 9 years
2. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
3. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
4. 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).
5. Subject has a history of colorectal cancer or advanced adenoma.
6. Subject has a history of aerodigestive tract cancer
7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
8. 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)

9. 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.
   • 2 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.

10. 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").
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal Cancer Incidence	Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3)	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of a positive Cologuard result at baseline (T0)	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).	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).	The sensitivity and specificity of Cologuard at year 3 (T3).	3 years
The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3).	The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3).	3 years
The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR).	The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR).	3 years
The probability that a negative Cologuard result at baseline remains negative through 3 years.	The probability that a negative Cologuard result at baseline remains negative through 3 years.	3 years
The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years.	The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years.	3 years
The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3	The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3	3 years
Adherence to repeat Cologuard at year 3 (T3)	Adherence to repeat Cologuard at T3 will be reported with counts and proportions.	3 years
Compliance to colonoscopy following a positive Cologuard result	Cumulative compliance to colonoscopy following a positive Cologuard result	baseline
Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3	Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3	Years 1, 2, and 3
The rate of no Cologuard result (e.g. invalid result)	The rate of no Cologuard result (e.g. invalid result)	3 years
The adverse event rate (events occurring between collection kit distribution and sample submission)	The adverse event rate (events occurring between collection kit distribution and sample submission)	3 years

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Investigators: Principal Investigator: Thomas Imperiale, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: colorectal cancer; Colorectal cancer screening
• 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: Exact Sciences 2014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)