Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
Conditions
Inflammatory Bowel Disease (IBD) - Primary Sclerosing Cholangitis (PSC) - Colorectal Neoplasms - Colorectal Cancer
Conditions: official terms
Cholangitis - Cholangitis, Sclerosing - Colorectal Neoplasms - Inflammatory Bowel Diseases - Intestinal Diseases
Conditions: Keywords
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, Inflammatory Bowel Disease, Primary Sclerosing Cholangitis
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Cross-Sectional
Overall Status
Recruiting
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.
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 grade dysplasia (HGD) and low grade dysplasia (LGD) associated with IBD and advanced adenoma in IBD patients with disease duration greater than 8 years or PSC diagnosis. Enrolled subjects will provide a single stool sample for the Exact IBD-ACRN surveillance test, no sooner than 7 days following their most recent pre-enrollment colonoscopy, within 30 days of enrollment and prior to initiating bowel prep for either the post-enrollment colonoscopy (surveillance or repeat), or surgical intervention. Stool samples will be tested using the Exact IBD-ACRN surveillance test and results compared to the colonoscopy and corresponding diagnostic histopathology results from biopsied, and any subsequently excised, lesions to establish sensitivity and specificity of the Exact IBD-ACRN surveillance test. All post-enrollment colonoscopies or surgical interventions must be performed within 60 days of enrollment.

The primary objective of this study is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for CRC in IBD patients with disease duration of at least eight years or diagnosis of PSC. Tissue diagnosis of CRC will be established by histopathology examination. The secondary objective is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test to detect ACRN in IBD patients with disease duration of at least eight years or diagnosis of PSC.

Enrollment will continue until at least 35 CRC; 15 HGD and 315 negative subject samples have been obtained. There is no specific recruitment goal for IBD associated LGD or LGD associated with advanced adenoma (AA).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 84 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 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 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.
Locations
Mayo Clinic Arizona
Phoenix, Arizona, United States
Status: Terminated
UC San Diego Medical Center
La Jolla, California, United States
Status: Recruiting
Contact: Ara Miralles - 858-657-6812 - amiralles@ucsd.edu
University of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Claudia Escobar - 305-243-3767 - c.escobar3@med.miami.edu
Rush University Medical Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Prachi Chakradeo - 312-942-9203 - Prachi_S_Charadeo@rush.edu
University of Chicago Medicine
Chicago, Illinois, United States
Status: Recruiting
Contact: Rosa Arrieta - 773-702-5382 - rarrieta@surgery.bsd.uchicago.edu
NorthShore University Health System
Evanston, Illinois, United States
Status: Terminated
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Status: Terminated
MGG Group, Co. Inc./Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Status: Recruiting
Contact: Alexa White - 301-654-2521 - alexa.white@capitaldigestivecare.com
Boston Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Sherida Padilla - 617-638-6527 - Sherida.padilla@bmc.org
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Melissa Cohen - 617-724-3238 - Mcohen4@mgh.harvard.edu
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States
Status: Terminated
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Julie Simonson - 949-224-2852 - simonson.julie@mayo.edu
Center for Digestive and Liver Diseases, Inc
Mexico, Missouri, United States
Status: Terminated
Medical Research Associates of New York
New York, New York, United States
Status: Terminated
Mount Sinai School of Medicine
New York, New York, United States
Status: Recruiting
Contact: Cristina Villagra - 212-824-7804 - cristina.villagra@mssm.edu
Asheville Gastroeneterology Associates
Asheville, North Carolina, United States
Status: Recruiting
Contact: Tonya Jones - 828-254-0881 - tonya.jones@ashevillegastro.com
Univeristy of North Carolina
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Celeste Cantrell - 919-966-0764 - cdcantre@email.unc.edu
Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Contact: Keyonna Smith - 216-444-3105 - smithk4@ccf.org
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Erin Landry - 615-322-4573 - Erin.vozar@vanderbilt.edu
Houston Methodist Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Karen Woodard - 713-441-4332 - klwoodard@houstonmethodist.org
Advanced Research Institute
Logan, Utah, United States
Status: Terminated
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Status: Terminated
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Status: Recruiting
Contact: Kelly Richie - 608-262-5404 - kr2@medicine.wisc.edu
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Status: Terminated
University of Calgary
Calgary, Alberta, Canada
Status: Recruiting
Contact: John Oshiomogho - 1-403-210-9601 - jioshiom@ucalgary.ca
Winnipeg Regional Health Authority-Health Sciences
Winnipeg, Manitoba, Canada
Status: Recruiting
Contact: Norine Miller - 204-787-4741 - nmiller@hsc.mb.ca
Start Date
March 2013
Completion Date
March 2017
Sponsors
Exact Sciences Corporation
Source
Exact Sciences Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page