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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503696
• Other study ID #: 2014-05
• Status: Completed
• Phase: N/A
• First received: July 17, 2015
• Last updated: August 9, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• 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.

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.

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Diseases
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Diseases
• Gastrointestinal Diseases
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Neoplasms

Intervention

Device:
• Stool Collection Kit
Stool Collection Kit.

Locations

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

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 CRC diagnostic screening test.	The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.	15 months	No