Fecal Immunochemical Testing as a Tool to Determine the Need for Colonoscopy in Symptomatic Patients
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- NL-OMON20343
- Lead Sponsor
- Erasmus MC (s-Gravendijkwal 230 3015 CE Rotterdam P.O. Box 2040, 3000 CA Rotterdam Phone: +31 10 704 0704) and Sysmex Europe (Postbus 251 4870 AG Etten-Leur Phone: +31(0)765086000)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 807
Inclusion Criteria
1. Referral for a diagnostic colonoscopy because of (new) bowel symptoms.
2. Able to undergo colonoscopy.
Exclusion Criteria
Subjects will be excluded if they are referred for colonoscopy surveillance for other
indications (including hereditary CRC syndrome, familial CRC syndrome, inflammatory
bowel disease, history of colorectal adenoma or CRC)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The performance of 2-sample FIT to detect advanced neoplasia by defining its negative predictive value, positive predictive value, sensitivity and specificity.
- Secondary Outcome Measures
Name Time Method The added value in NPV for performing two FIT’s instead of one will be evaluated by<br>describing the added value in NPV (d). <br>We will describe the performance of a selection model that combines both symptoms,<br>patient characteristics and FIT to detect advanced neoplasia by defining its negative<br>predictive value, positive predictive value, sensitivity and specificity.<br>We will also describe<br>the performance of FIT for different cut-off values by the above mentioned test<br>characteristics.