Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
OCEANIA
1 other identifier
observational
440
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
26 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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 17, 2017
August 1, 2016
3.8 years
March 25, 2013
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD.
9 months
Study Arms (1)
IBD or PSC
Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer.
Eligibility Criteria
Subjects who have diagnosed IBD and are undergoing a colorectal cancer surveillance program. Also, have either a histopathological diagnosis of high grade dysplasia or colorectal cancer resulting from colonoscopy preceding enrollment or for whom a surveillance colonscopy is indicated.
You may qualify if:
- 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.
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
UC San Diego Medical Center
La Jolla, California, 92093-0956, United States
University of Miami
Miami, Florida, 33136, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
MGG Group, Co. Inc./Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, 48334, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Center for Digestive and Liver Diseases, Inc
Mexico, Missouri, 65265, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Medical Research Associates of New York
New York, New York, 10075, United States
Asheville Gastroeneterology Associates
Asheville, North Carolina, 28801, United States
Univeristy of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Advanced Research Institute
Logan, Utah, 84341, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
Winnipeg Regional Health Authority-Health Sciences
Winnipeg, Manitoba, R3A 1R9, Canada
Biospecimen
Residual samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subject. Specimens will be stored in a commercial biorepository contracted by Exact Sciences or at Exact Sciences and may be used for future research.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Itzkowitz, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2013
First Posted
March 28, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 17, 2017
Record last verified: 2016-08