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NCT01819766 · ClinicalTrials.gov registry record
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
A clinical trial, sponsored by Exact Sciences Corporation.
- Completed
- Registry status
- 440
- Enrollment target
NCT01819766: Completed study, sponsored by Exact Sciences Corporation.
NCT01819766 is a clinical trial that has completed, run by Exact Sciences Corporation. The registered enrollment target is 440 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819766 has completed, sponsored by Exact Sciences Corporation.
- COMPLETED
- Registry status
- 440 participants
- Enrollment target
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2013-03 |
| Est. Completion | 2017-01 |
What the finished NCT01819766 record still lists
NCT01819766 is an observational study that tracks outcomes without assigning an intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01819766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01819766 about?
NCT01819766 is a clinical study titled "Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease". 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 (P...
What is the current status of trial NCT01819766?
This trial is currently completed. The enrollment target is 440 participants. The study started on 2013-03. Estimated completion is 2017-01.
Who is sponsoring clinical trial NCT01819766?
This trial is sponsored by Exact Sciences Corporation, which has 30 total clinical trials registered on ClinicalTrials.gov.
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