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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01819766
First Posted: March 28, 2013
Last Update Posted: February 17, 2017
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.
Information provided by (Responsible Party):
Exact Sciences Corporation
March 25, 2013
March 28, 2013
February 17, 2017
March 2013
January 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01819766 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
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).

Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
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.
Non-Probability Sample
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.
  • Inflammatory Bowel Disease (IBD)
  • Primary Sclerosing Cholangitis (PSC)
  • Colorectal Neoplasms
  • Colorectal Cancer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
January 2017
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 84 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01819766
Exact Sciences 2013-01
No
Not Provided
Not Provided
Exact Sciences Corporation
Exact Sciences Corporation
Not Provided
Principal Investigator: Steven Itzkowitz, MD Icahn School of Medicine at Mount Sinai
Exact Sciences Corporation
August 2016