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

Completed

Conditions studied: Colorectal Cancer Screening, Colorectal Cancer

In brief

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

Key facts

Study ID

NCT02419716

Run by

Exact Sciences Corporation

People needed

2404

Starts

2015-04-01

Expected to finish

2020-03-16

Last updated by the study team

2020-04-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

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.
• 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.
• 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.

Where it is running

• Thomas C Lenzmeier, M.D., P.C — Glendale, Arizona, United States
• Central Arizona Medical Associates, PC — Mesa, Arizona, United States
• Fiel Family and Sports Medicine — Tempe, Arizona, United States
• Cassidy Medical Group/Radiant Research, Inc. — Carlsbad, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Paragon Rx Clinical — Garden Grove, California, United States
• UCLA, Division of Digestive Diseases — Los Angeles, California, United States
• FACEY Medical Foundation — Mission Hills, California, 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
• Advanced Pain Diagnostics & Solutions — Sacramento, California, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• Homestead Medical Research — Homestead, Florida, United States
• Health Awareness, Inc — Jupiter, Florida, United States
• Precision Clinical Research — Lauderdale Lakes, Florida, United States
• Advanced Bioresearch — Miami, Florida, United States
• Next Phase Research Alliance — Miami, Florida, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• Health Awareness, Inc-Port St. Lucie — Port Saint Lucie, Florida, United States
• The Kaufmann Clinic, Inc. — Atlanta, Georgia, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Pharmakon Inc — Evergreen Park, Illinois, United States
• Indiana University, Eskanazi Hospital, Regenstrief Health Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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