Trial record 5 of 1907 for:    Open Studies | "Intestinal Diseases"

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 2014 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 7, 2014
Last verified: May 2014
  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 60 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: 320
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (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 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).

  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 with duration of at least eight years, or a diagnosis or PSC. 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 for at least eight years (or any duration with a diagnosis of HGD or CRC), or diagnosis of PSC with IBD of any duration, 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: Sandra Statz, MS 608-284-5674 sstatz@exactsciences.com

Locations
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Joy Few    480-342-2131    Few.Joy@mayo.edu   
Principal Investigator: Russell Heigh, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Claudia Escobar    305-243-3767    c.escobar3@med.miami.edu   
Principal Investigator: Daniel Sussman, MD         
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Rosa Arrieta    773-702-5382    rarrieta@surgery.bsd.uchicago.edu   
Principal Investigator: David Rubin, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Prachi Chakradeo    312-942-9203    Prachi_S_Charadeo@rush.edu   
Principal Investigator: Ece Mutlu, MD         
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Asantewaa Ture    847-570-3708    ature@northshore.org   
Principal Investigator: Eugene Yen, MD         
United States, Louisiana
Gastroenterology Associates, LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Regina Williams    225-231-8737    rwilliams@dhcla.com   
Principal Investigator: Prasad Alapati, MD         
United States, Maryland
MGG Group, Co. Inc./Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Alexa White    301-654-2521 ext 2106    alexa.white@capitaldigestivecare.com   
Principal Investigator: Robert Hardi, MD         
United States, Michigan
Detroit Clinical Research Center, PC Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Sonia Amin    248-716-7011    sonia.amin@dcrc.us   
Principal Investigator: Steven Katzman, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Julie Simonson    949-224-2852    simonson.julie@mayo.edu   
Principal Investigator: John Kisiel, MD         
United States, Missouri
Center for Digestive and Liver Diseases, Inc Recruiting
Mexico, Missouri, United States, 65265
Contact: Jennifer Bell    573-581-7196    Jennifer.Bell@gutdoc.us   
Principal Investigator: Glenn Gordon, MD         
United States, New York
Medical Research Associates of New York Terminated
New York, New York, United States, 10075
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Cristina Villagra    212-824-7804    cristina.villagra@mssm.edu   
Principal Investigator: Steven Itzkowitz, MD         
United States, North Carolina
Asheville Gastroeneterology Associates Recruiting
Asheville, North Carolina, United States, 28801
Contact: Tonya Jones    828-254-0881    tonya.jones@ashevillegastro.com   
Principal Investigator: William Harlan, MD         
United States, Utah
Advanced Research Institute Terminated
Logan, Utah, United States, 84341
United States, Virginia
Blue Ridge Medical Research Recruiting
Lynchburg, Virginia, United States, 24502
Contact: Mary Robinson    434-455-8661    m.robinson@gastrocentralva.com   
Principal Investigator: Larry Clark, MD         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kelly Richie    608-262-5404    kr2@medicine.wisc.edu   
Principal Investigator: Mark Reichelderfer, MD         
Wisconsin Center for Advanced Research Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Kathy Anderson    414-908-6630    KathyA@wigia.com   
Principal Investigator: Daniel Geenen, MD         
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 7, 2014
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
Neoplasms
Cholangitis
Cholangitis, Sclerosing
Colorectal Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on July 24, 2014