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

Sponsor

Exact Sciences Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01819766

Collaborator

(none)

440

Enrollment

Locations

46.1

Duration (Months)

16.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease (IBD) Primary Sclerosing Cholangitis (PSC) Colorectal Neoplasms Colorectal Cancer

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

440 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC. [9 months]
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.

Secondary Outcome Measures

Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD. [9 months]
Subjects with colonoscopic findings of CRC and/or high grade dysplasia (HGD) will be considered to have a positive outcome for composite CRC-HGD sensitivity calculations. Subjects with negative colonoscopic findings will be considered to have a negative outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University of Chicago Medicine	Chicago	Illinois	United States	60637
6	NorthShore University Health System	Evanston	Illinois	United States	60201
7	Gastroenterology Associates, LLC	Baton Rouge	Louisiana	United States	70809
8	MGG Group, Co. Inc./Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
9	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
10	Boston Medical Center	Boston	Massachusetts	United States	02118
11	Detroit Clinical Research Center, PC	Farmington Hills	Michigan	United States	48334
12	Mayo Clinic	Rochester	Minnesota	United States	55905
13	Center for Digestive and Liver Diseases, Inc	Mexico	Missouri	United States	65265
14	Mount Sinai School of Medicine	New York	New York	United States	10029
15	Medical Research Associates of New York	New York	New York	United States	10075
16	Asheville Gastroeneterology Associates	Asheville	North Carolina	United States	28801
17	Univeristy of North Carolina	Chapel Hill	North Carolina	United States	27599
18	Cleveland Clinic	Cleveland	Ohio	United States	44195
19	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212-1610
20	Houston Methodist Hospital	Houston	Texas	United States	77030
21	Advanced Research Institute	Logan	Utah	United States	84341
22	Blue Ridge Medical Research	Lynchburg	Virginia	United States	24502
23	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
24	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin	United States	53215
25	University of Calgary	Calgary	Alberta	Canada	T2N 1N4
26	Winnipeg Regional Health Authority-Health Sciences	Winnipeg	Manitoba	Canada	R3A 1R9