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

NCT ID: NCT01819766

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-01-31

Brief Summary

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.

Detailed Description

This is a prospective, cross sectional, multi-center study to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for detecting CRC alone and in combination with high grade dysplasia (HGD) and low grade dysplasia (LGD) associated with IBD and advanced adenoma in IBD patients with disease duration greater than 8 years or PSC diagnosis. Enrolled subjects will provide a single stool sample for the Exact IBD-ACRN surveillance test, no sooner than 7 days following their most recent pre-enrollment colonoscopy, within 30 days of enrollment and prior to initiating bowel prep for either the post-enrollment colonoscopy (surveillance or repeat), or surgical intervention. Stool samples will be tested using the Exact IBD-ACRN surveillance test and results compared to the colonoscopy and corresponding diagnostic histopathology results from biopsied, and any subsequently excised, lesions to establish sensitivity and specificity of the Exact IBD-ACRN surveillance test. All post-enrollment colonoscopies or surgical interventions must be performed within 60 days of enrollment.

The primary objective of this study is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for CRC in IBD patients with disease duration of at least eight years or diagnosis of PSC. Tissue diagnosis of CRC will be established by histopathology examination. The secondary objective is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test to detect ACRN in IBD patients with disease duration of at least eight years or diagnosis of PSC.

Enrollment will continue until at least 35 CRC; 15 HGD and 315 negative subject samples have been obtained. There is no specific recruitment goal for IBD associated LGD or LGD associated with advanced adenoma (AA).

Conditions

Inflammatory Bowel Disease (IBD); Primary Sclerosing Cholangitis (PSC); Colorectal Neoplasms; Colorectal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

IBD or PSC

Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exact Sciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Itzkowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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

Winnipeg Regional Health Authority-Health Sciences

Winnipeg, Manitoba, Canada

Countries

United States; Canada

Other Identifiers

Exact Sciences 2013-01

Identifier Type: -

Identifier Source: org_study_id