Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease (IBD); Primary Sclerosing Cholangitis (PSC); Colorectal Neoplasms; Colorectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms; Intestinal Diseases; Inflammatory Bowel Diseases; Cholangitis; Cholangitis, Sclerosing
Study type: Observational

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.
    

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).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
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.
      
Biospecimen 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.
    
Keywords: 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