Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
1 other identifier
observational
697
2 countries
29
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 10, 2016
August 1, 2016
1.2 years
July 17, 2015
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
IBD
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.
Interventions
Eligibility Criteria
Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
UC San Diego Medical Center
La Jolla, California, 92093, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Medical Research Center of Conneticut
Hamden, Connecticut, 06518, United States
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
HealthEast Midway Clinic
Saint Paul, Minnesota, 55104, United States
Gastrointestinal Associates
Jackson, Mississippi, 39202, United States
AGA Clinical Research Associates, LLC
Egg Harbor TWP, New Jersey, 08234, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Kinston Medical Specialists, PA
Kinston, North Carolina, 28501, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
UC Health
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
University of Calgary - Division of Gastroenterology
Calgary, Alberta, T2N1N4, Canada
Winnipeg Regional Health Authority- Health Sciences
Winnipeg, Manitoba, R3A 1R9, Canada
Biospecimen
Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Graham Lidgard, PhD
Exact Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 21, 2015
Study Start
September 1, 2014
Primary Completion
November 1, 2015
Study Completion
June 1, 2016
Last Updated
August 10, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share