Clinical trial NCT02419716: A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
Official title: A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Screening
Colorectal Cancer
Keywords: colorectal cancer
Colorectal cancer screening
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 2404
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive and Negative Predictive Value
timeFrame: Three years
Secondary outcomes:
measure: Colorectal Cancer Incidence
timeFrame: 3 years
Other outcomes:
measure: Predictive value of a positive Cologuard result at baseline (T0)
timeFrame: baseline
measure: The predicative value of a positive and a negative Cologuard at year 3 (T3).
timeFrame: 3 years
measure: The sensitivity and specificity of Cologuard at year 3 (T3).
timeFrame: 3 years
measure: The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3).
timeFrame: 3 years
measure: The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR).
timeFrame: 3 years
measure: The probability that a negative Cologuard result at baseline remains negative through 3 years.
timeFrame: 3 years
measure: The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years.
timeFrame: 3 years
measure: The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3
timeFrame: 3 years
measure: Adherence to repeat Cologuard at year 3 (T3)
timeFrame: 3 years
measure: Compliance to colonoscopy following a positive Cologuard result
timeFrame: baseline
measure: Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3
timeFrame: Years 1, 2, and 3
measure: The rate of no Cologuard result (e.g. invalid result)
timeFrame: 3 years
measure: The adverse event rate (events occurring between collection kit distribution and sample submission)
timeFrame: 3 years
Locations:
city: Glendale
country: United States
facility: Thomas C Lenzmeier, M.D., P.C
state: Arizona
city: Mesa
country: United States
facility: Central Arizona Medical Associates, PC
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: Carlsbad
country: United States
facility: Cassidy Medical Group/Radiant Research, Inc.
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical
state: California
city: Los Angeles
country: United States
facility: UCLA, Division of Digestive Diseases
state: California
city: Mission Hills
country: United States
facility: FACEY Medical Foundation
state: California
city: Newport Beach
country: United States
facility: John D. Homan, MD
state: California
city: Oxnard
country: United States
facility: Diverse Research Solutions
state: California
city: Oxnard
country: United States
facility: Ventura County Gastroenterology
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Sacramento
country: United States
facility: Advanced Pain Diagnostics & Solutions
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Homestead
country: United States
facility: Homestead Medical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc
state: Florida
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Bioresearch
state: Florida
city: Miami
country: United States
facility: Next Phase Research Alliance
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc-Port St. Lucie
state: Florida
city: Atlanta
country: United States
facility: The Kaufmann Clinic, Inc.
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Evergreen Park
country: United States
facility: Pharmakon Inc
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University, Eskanazi Hospital, Regenstrief Health Center
state: Indiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Associates
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
city: Henderson
country: United States
facility: Nevada Family Care
state: Nevada
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Sentral Clinical Research
state: Ohio
city: Wooster
country: United States
facility: Comprehensive Internal Medicine, Inc.
state: Ohio
city: Wooster
country: United States
facility: Family Practice Center of Wooster, Inc./Clinical Trial Developers
state: Ohio
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Montgomery
country: United States
facility: PCP for Life (DM Research)
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
affiliation: Indiana University
name: Thomas Imperiale, MD
role: PRINCIPAL_INVESTIGATOR
References: