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

Colorectal Cancer Clinical Trial

— OCEANIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819766
• Other study ID #: Exact Sciences 2013-01
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: February 16, 2017
• Start date: March 2013
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Neoplasms
• Primary Sclerosing Cholangitis (PSC)

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Winnipeg Regional Health Authority-Health Sciences	Winnipeg	Manitoba
United States	Asheville Gastroeneterology Associates	Asheville	North Carolina
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Univeristy of North Carolina	Chapel Hill	North Carolina
United States	MGG Group, Co. Inc./Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	NorthShore University Health System	Evanston	Illinois
United States	Detroit Clinical Research Center, PC	Farmington Hills	Michigan
United States	Houston Methodist Hospital	Houston	Texas
United States	UC San Diego Medical Center	La Jolla	California
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	Center for Digestive and Liver Diseases, Inc	Mexico	Missouri
United States	University of Miami	Miami	Florida
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
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	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC.	With comparison to the colonoscopy results and histopathologic diagnosis of all lesions discovered during colonoscopy and either biopsied or removed during or subsequently removed after colonoscopy.	9 months
Secondary	Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD.	Subjects with colonoscopic findings of CRC and/or high grade dysplasia (HGD) will be considered to have a positive outcome for composite CRC-HGD sensitivity calculations. Subjects with negative colonoscopic findings will be considered to have a negative outcome.	9 months