Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease



Status:Completed
Conditions:Colorectal Cancer, Cancer, Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - 84
Updated:2/18/2017
Start Date:March 2013
End Date:January 2017

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Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study

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.

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).

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.
We found this trial at
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sites
Chevy Chase, Maryland 20815
Principal Investigator: Robert Hardi, MD
Phone: 301-654-2521
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ashwin Ananthakrishnan, MD
Phone: 617-724-3238
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Jean Achkar, MD
Phone: 216-444-3105
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Daniel Sussman, MD
Phone: 305-243-3767
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: David Schwartz, MD
Phone: 615-322-4573
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Asheville, North Carolina 28801
Principal Investigator: William Harlan, MD
Phone: 828-254-0881
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Baton Rouge, Louisiana 70809
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Boston, Massachusetts 02118
Principal Investigator: Francis Farraye, MD
Phone: 617-638-6527
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Calgary, Alberta
Principal Investigator: Marietta Iacucci, MD
Phone: 1-403-210-9601
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Chapel Hill, North Carolina 27599
Principal Investigator: Millie Long, MD
Phone: 919-966-0764
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Ece Mutlu, MD
Phone: 312-942-9203
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, Illinois 60637
Principal Investigator: David Rubin, MD
Phone: 773-702-5382
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Evanston, Illinois 60201
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Farmington Hills, Michigan 48334
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Bincy Abraham, MD
Phone: 713-441-4332
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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La Jolla, California 92093
Principal Investigator: William Sandborn, MD
Phone: 858-657-6812
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Logan, Utah 84341
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Lynchburg, Virginia 24502
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Mark Reichelderfer, MD
Phone: 608-262-5404
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Milwaukee, Wisconsin 53215
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New York, New York 10075
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New York, New York 10029
Principal Investigator: Steven Itzkowitz, MD
Phone: 212-824-7804
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Phoenix, Arizona 85054
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Rochester, Minnesota 55905
Principal Investigator: John Kisiel, MD
Phone: 949-224-2852
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