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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Exact Sciences Corporation
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01819766
First received: March 25, 2013
Last updated: May 14, 2015
Last verified: May 2015
  Purpose

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
Inflammatory Bowel Disease (IBD)
Primary Sclerosing Cholangitis (PSC)
Colorectal Neoplasms
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study

Resource links provided by NLM:


Further study details as provided by Exact Sciences Corporation:

Primary Outcome Measures:
  • Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 440
Study Start Date: March 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819766

Contacts
Contact: Toby Vaughn 608-210-5131 tvaughn@exactsciences.com

  Show 26 Study Locations
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
Principal Investigator: Steven Itzkowitz, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01819766     History of Changes
Other Study ID Numbers: Exact Sciences 2013-01
Study First Received: March 25, 2013
Last Updated: May 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Exact Sciences Corporation:
Intestinal Diseases
Inflammatory Bowel Disease
Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Primary Sclerosing Cholangitis

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

ClinicalTrials.gov processed this record on May 21, 2015