Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)

Completed

Conditions studied: Inflammatory Bowel Disease, Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

In brief

The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).

Key facts

Study ID

NCT02503696

Run by

Exact Sciences Corporation

People needed

697

Starts

2014-09-01

Expected to finish

2016-06-01

Last updated by the study team

2016-08-10

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
• Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
• Written informed consent document signed and dated by the subject.

You may not qualify if…

• Any condition that in the opinion of the investigator should preclude participation in the study.
• A history of aerodigestive tract cancer.
• Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
• IBD limited only to the rectum.
• Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.

Where it is running

• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• UC San Diego Medical Center — La Jolla, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Medical Research Center of Conneticut — Hamden, Connecticut, United States
• Edward Hines Jr. VA Hospital — Hines, Illinois, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• HealthEast Midway Clinic — Saint Paul, Minnesota, United States
• Gastrointestinal Associates — Jackson, Mississippi, United States
• AGA Clinical Research Associates, LLC — Egg Harbor TWP, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Kinston Medical Specialists, PA — Kinston, North Carolina, United States
• Digestive Health Specialists, PA — Winston-Salem, North Carolina, United States
• UC Health — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Charlottesville Medical Research Center, LLC — Charlottesville, Virginia, United States
• Gastroenterology Associates of Tidewater — Chesapeake, Virginia, United States
• Blue Ridge Medical Research — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.