A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
This trial is active, not recruiting.
|Conditions||colorectal cancer screening, colorectal cancer|
|Sponsor||Exact Sciences Corporation|
|Start date||April 2015|
|End date||March 2019|
|Trial size||2173 participants|
|Trial identifier||NCT02419716, Exact Sciences 2014-01|
This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
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|Glendale, AZ||Thomas C Lenzmeier, M.D., P.C||no longer recruiting|
|Mesa, AZ||Central Arizona Medical Associates, PC||no longer recruiting|
|Tempe, AZ||Fiel Family and Sports Medicine||no longer recruiting|
|Carlsbad, CA||Cassidy Medical Group/Radiant Research, Inc.||no longer recruiting|
|Corona, CA||Kindred Medical Institute for Clinical Trials, LLC||no longer recruiting|
|Garden Grove, CA||Paragon Rx Clinical||no longer recruiting|
|Los Angeles, CA||UCLA, Division of Digestive Diseases||no longer recruiting|
|Newport Beach, CA||John D. Homan, MD||no longer recruiting|
|Oxnard, CA||Diverse Research Solutions||no longer recruiting|
|Oxnard, CA||Ventura County Gastroenterology||no longer recruiting|
|Palm Springs, CA||Desert Oasis Healthcare Medical Group||no longer recruiting|
|Sacramento, CA||Advanced Pain Diagnostics & Solutions||no longer recruiting|
|Clearwater, FL||Innovative Research of West Florida||no longer recruiting|
|Homestead, FL||Homestead Medical Research||no longer recruiting|
|Jupiter, FL||Health Awareness, Inc||no longer recruiting|
|Lauderdale Lakes, FL||Sunrise Medical Research, Inc.||no longer recruiting|
|Miami, FL||Advanced Bioresearch||no longer recruiting|
|Miami, FL||Next Phase Research Alliance||no longer recruiting|
|Pompano Beach, FL||Clinical Research Center of Florida||no longer recruiting|
|Port St. Lucie, FL||Health Awareness, Inc-Port St. Lucie||no longer recruiting|
|Atlanta, GA||The Kaufmann Clinic, Inc.||no longer recruiting|
|Meridian, ID||Advanced Clinical Research||no longer recruiting|
|Evergreen Park, IL||Pharmakon Inc||no longer recruiting|
|Indianapolis, IN||Indiana University, Eskanazi Hospital, Regenstrief Health Center||no longer recruiting|
|Metairie, LA||MedPharmics, LLC||no longer recruiting|
|Columbia, MD||Columbia Medical Practice||no longer recruiting|
|Elkridge, MD||Centennial Medical Associates||no longer recruiting|
|Rochester, MN||Mayo Clinic Minnesota||no longer recruiting|
|Henderson, NV||Nevada Family Care||no longer recruiting|
|Binghamton, NY||United Medical Associates||no longer recruiting|
|Endwell, NY||Regional Clinical Research, Inc.||no longer recruiting|
|Chapel Hill, NC||University of North Carolina, Chapel Hill||no longer recruiting|
|Cincinnati, OH||Sentral Clinical Research||no longer recruiting|
|Wooster, OH||Comprehensive Internal Medicine, Inc.||no longer recruiting|
|Wooster, OH||Family Practice Center of Wooster, Inc./Clinical Trial Developers||no longer recruiting|
|Harleysville, PA||Harleysville Medical Associates||no longer recruiting|
|Austin, TX||Austin Regional Clinic||no longer recruiting|
|Montgomery, TX||PCP for Life (DM Research)||no longer recruiting|
|Salt Lake City, UT||Wasatch Clinical Research||no longer recruiting|
Positive and Negative Predictive Value
time frame: Three years
Colorectal Cancer Incidence
time frame: 3 years
Male or female participants at least 50 years old.
- 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.
- 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.
|Official title||A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval|
|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.|
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