Clinical trial NCT02503696: Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Official title: Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer
Keywords: Inflammatory Bowel Disease
Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 697
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity of the Exact CRC diagnostic screening test.
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego Medical Center
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Hamden
country: United States
facility: Medical Research Center of Conneticut
state: Connecticut
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital
state: Illinois
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Paul
country: United States
facility: HealthEast Midway Clinic
state: Minnesota
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Egg Harbor TWP
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary - Division of Gastroenterology
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority- Health Sciences
state: Manitoba
Study officials:
affiliation: Exact Sciences
name: Graham Lidgard, PhD
role: STUDY_CHAIR
References: