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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01819766
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):

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
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
Estimated 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 : March 2013
Primary Completion Date : January 2017
Study Completion Date : January 2017


Groups and Cohorts

Group/Cohort
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 :
  1. Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC. [ Time Frame: 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 :
  1. Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819766


  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
UC San Diego Medical Center
La Jolla, California, United States, 92093-0956
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medicine
Chicago, Illinois, United States, 60637
NorthShore University Health System
Evanston, Illinois, United States, 60201
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
MGG Group, Co. Inc./Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Center for Digestive and Liver Diseases, Inc
Mexico, Missouri, United States, 65265
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Medical Research Associates of New York
New York, New York, United States, 10075
United States, North Carolina
Asheville Gastroeneterology Associates
Asheville, North Carolina, United States, 28801
Univeristy of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1610
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Advanced Research Institute
Logan, Utah, United States, 84341
United States, Virginia
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Canada, Manitoba
Winnipeg Regional Health Authority-Health Sciences
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
Principal Investigator: Steven Itzkowitz, MD Icahn School of Medicine at Mount Sinai
More Information

Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01819766     History of Changes
Other Study ID Numbers: Exact Sciences 2013-01
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: August 2016

Keywords provided by Exact Sciences Corporation:
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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Cholangitis
Cholangitis, Sclerosing
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Gastroenteritis
Bile Duct Diseases
Biliary Tract Diseases