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


N/A
18 Years
84 Years
Open (Enrolling)
Both
Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC), Colorectal Neoplasms, Colorectal Cancer

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Trial Information

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


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 30 CRC; 20 HGD and 240 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 for at least eight years, or diagnosis of PSC, prior to enrollment
date of this study.

- 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.

- IBD limited only to the rectum

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC.

Outcome Description:

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.

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Steven Itzkowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Icahn School of Medicine at Mount Sinai

Authority:

United States: Institutional Review Board

Study ID:

Exact Sciences 2013-01

NCT ID:

NCT01819766

Start Date:

March 2013

Completion Date:

December 2013

Related Keywords:

  • Inflammatory Bowel Disease (IBD)
  • Primary Sclerosing Cholangitis (PSC)
  • Colorectal Neoplasms
  • Colorectal Cancer
  • 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
  • Neoplasms
  • Cholangitis
  • Cholangitis, Sclerosing
  • Colorectal Neoplasms
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Wisconsin Center for Advanced ResearchMilwaukee, Wisconsin  53207
Advanced Research InstituteLogan, Utah  84341
Gastroenterology Associates, LLCBaton Rouge, Louisiana  70809
MGG Group, Co. Inc./Chevy Chase Clinical ResearchChevy Chase, Maryland  20815
Center for Digestive and Liver Diseases, IncMexico, Missouri  65265
Medical Research Associates of New YorkNew York, New York  10075
Asheville Gastroeneterology AssociatesAsheville, North Carolina  28801