Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease

Completed

Conditions studied: Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC), Colorectal Neoplasms, Colorectal Cancer

In brief

This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.

Key facts

Study ID

NCT01819766

Run by

Exact Sciences Corporation

People needed

440

Starts

2013-03-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-17

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.
• Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study.
• Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC.
• Written informed consent document signed and dated by the subject or legally acceptable representative.

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 and without a concurrent PSC diagnosis.
• Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• UC San Diego Medical Center — La Jolla, California, United States
• University of Miami — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• MGG Group, Co. Inc./Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Detroit Clinical Research Center, PC — Farmington Hills, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Center for Digestive and Liver Diseases, Inc — Mexico, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Medical Research Associates of New York — New York, New York, United States
• Asheville Gastroeneterology Associates — Asheville, North Carolina, United States
• Univeristy of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Advanced Research Institute — Logan, Utah, United States
• Blue Ridge Medical Research — Lynchburg, Virginia, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Wisconsin Center for Advanced Research — Milwaukee, Wisconsin, United States
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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