Status:
COMPLETED
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
Lead Sponsor:
Exact Sciences Corporation
Conditions:
Inflammatory Bowel Disease (IBD)
Primary Sclerosing Cholangitis (PSC)
Eligibility:
All Genders
18-84 years
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). Patie...
Detailed Description
This is a prospective, cross sectional, multi-center study to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for detecting CRC alone and in combination with high gra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT01819766
Start Date
March 1 2013
End Date
January 1 2017
Last Update
February 17 2017
Active Locations (26)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
UC San Diego Medical Center
La Jolla, California, United States, 92093-0956
3
University of Miami
Miami, Florida, United States, 33136
4
Rush University Medical Center
Chicago, Illinois, United States, 60612