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

Completed

• Conditions: Colorectal Neoplasms; Colonic Diseases; Digestive System Diseases; Colorectal Cancer; Inflammatory Bowel Disease
• Interventions: Device: Stool Collection Kit

• Registration Number: NCT02503696
• Lead Sponsor: Exact Sciences Corporation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-21
• Primary Completion: 2015-11
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 697

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD	Stool Collection Kit	Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the Exact CRC diagnostic screening test.	15 months	The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.

Trial Locations

Locations (29)

Edward Hines Jr. VA Hospital; 🇺🇸 Hines, Illinois, United States

Digestive Health Specialists of the Southeast; 🇺🇸 Dothan, Alabama, United States

Medical Research Center of Conneticut; 🇺🇸 Hamden, Connecticut, United States

Gastroenterology Associates, LLC; 🇺🇸 Baton Rouge, Louisiana, United States

Facey Medical Foundation; 🇺🇸 Mission Hills, California, United States

UC San Diego Medical Center; 🇺🇸 La Jolla, California, United States

Gastroenterology Associates of Tidewater; 🇺🇸 Chesapeake, Virginia, United States

AGA Clinical Research Associates, LLC; 🇺🇸 Egg Harbor TWP, New Jersey, United States

Delta Research Partners; 🇺🇸 Monroe, Louisiana, United States

Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Blue Ridge Medical Research; 🇺🇸 Lynchburg, Virginia, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Louisiana Research Center, LLC; 🇺🇸 Shreveport, Louisiana, United States

HealthEast Midway Clinic; 🇺🇸 St. Paul, Minnesota, United States

Winnipeg Regional Health Authority- Health Sciences; 🇨🇦 Winnipeg, Manitoba, Canada

Gastrointestinal Associates; 🇺🇸 Jackson, Mississippi, United States

Asheville Gastroenterology Associates, PA; 🇺🇸 Asheville, North Carolina, United States

Kinston Medical Specialists, PA; 🇺🇸 Kinston, North Carolina, United States

Charlottesville Medical Research Center, LLC; 🇺🇸 Charlottesville, Virginia, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Digestive Health Specialists, PA; 🇺🇸 Winston-Salem, North Carolina, United States

UC Health; 🇺🇸 Cincinnati, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Wisconsin Center for Advanced Research; 🇺🇸 Milwaukee, Wisconsin, United States

University of Wisconsin Hospital & Clinics; 🇺🇸 Madison, Wisconsin, United States

University of Calgary - Division of Gastroenterology; 🇨🇦 Calgary, Alberta, Canada