A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

Colorectal Cancer Clinical Trial

Official title:

A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419716
• Other study ID #: Exact Sciences 2014-01
• Status: Completed
• Start date: April 2015
• Est. completion date: March 16, 2020

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2404
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Device:
• Cologuard
Prescription of Cologuard for at-home stool collection

Locations

Country	Name	City	State
United States	The Kaufmann Clinic, Inc.	Atlanta	Georgia
United States	Austin Regional Clinic	Austin	Texas
United States	United Medical Associates	Binghamton	New York
United States	Cassidy Medical Group/Radiant Research, Inc.	Carlsbad	California
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Sentral Clinical Research	Cincinnati	Ohio
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Columbia Medical Practice	Columbia	Maryland
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Centennial Medical Associates	Elkridge	Maryland
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Pharmakon Inc	Evergreen Park	Illinois
United States	Paragon Rx Clinical	Garden Grove	California
United States	Thomas C Lenzmeier, M.D., P.C	Glendale	Arizona
United States	Harleysville Medical Associates	Harleysville	Pennsylvania
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	Florida
United States	Precision Clinical Research	Lauderdale Lakes	Florida
United States	UCLA, Division of Digestive Diseases	Los Angeles	California
United States	Advanced Clinical Research	Meridian	Idaho
United States	Central Arizona Medical Associates, PC	Mesa	Arizona
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Advanced Bioresearch	Miami	Florida
United States	Next Phase Research Alliance	Miami	Florida
United States	FACEY Medical Foundation	Mission Hills	California
United States	PCP for Life (DM Research)	Montgomery	Texas
United States	John D. Homan, MD	Newport Beach	California
United States	Diverse Research Solutions	Oxnard	California
United States	Ventura County Gastroenterology	Oxnard	California
United States	Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Health Awareness, Inc-Port St. Lucie	Port Saint Lucie	Florida
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	Advanced Pain Diagnostics & Solutions	Sacramento	California
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Fiel Family and Sports Medicine	Tempe	Arizona
United States	Comprehensive Internal Medicine, Inc.	Wooster	Ohio
United States	Family Practice Center of Wooster, Inc./Clinical Trial Developers	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive value of a positive Cologuard result at baseline (T0)	Predictive value of a positive Cologuard result at baseline (T0)	baseline
Other	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
Other	The sensitivity and specificity of Cologuard at year 3 (T3).	The sensitivity and specificity of Cologuard at year 3 (T3).	3 years
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Adherence to repeat Cologuard at year 3 (T3)	Adherence to repeat Cologuard at T3 will be reported with counts and proportions.	3 years
Other	Compliance to colonoscopy following a positive Cologuard result	Cumulative compliance to colonoscopy following a positive Cologuard result	baseline
Other	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
Other	The rate of no Cologuard result (e.g. invalid result)	The rate of no Cologuard result (e.g. invalid result)	3 years
Other	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
Primary	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	Colorectal Cancer Incidence	Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3)	3 years