Clinical trialNCT01819766CompletedObservational

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

SponsorExact Sciences CorporationEnrollment440Colorectal CancerColorectal NeoplasmsInflammatory Bowel Disease (IBD)Primary Sclerosing Cholangitis (PSC)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Steven Itzkowitz, MD
Icahn School of Medicine at Mount Sinai
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

26 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University of Calgary
Calgary, Alberta, Canada
Winnipeg Regional Health Authority-Health Sciences
Winnipeg, Manitoba, Canada

United States

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
Boston Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
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
Medical Research Associates of New York
New York, New York, United States
Mount Sinai School of Medicine
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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2013
Primary completion: 31 Jan 2017
Completion: 31 Jan 2017
Last update posted: 17 Feb 2017
Registered enrollment: 440
Registry id: NCT01819766

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.