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

NCT01819766 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 440

Last updated 2017-02-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Exact Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Steven Itzkowitz, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819766 on ClinicalTrials.gov