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Fecal Immunochemical Testing as a Tool to Determine the Need for Colonoscopy in Symptomatic Patients

Fecal Immunochemical Testing as a Tool to Determine the Need for Colonoscopy in Symptomatic Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20343
Enrollment
807
Registered
2019-08-15
Start date
2019-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

None

Sponsors

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)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Referral for a diagnostic colonoscopy because of (new) bowel symptoms. 2. Able to undergo colonoscopy.

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The performance of 2-sample FIT to detect advanced neoplasia by defining its negative predictive value, positive predictive value, sensitivity and specificity.

Secondary

MeasureTime frame
The added value in NPV for performing two FIT’s instead of one will be evaluated by describing the added value in NPV (d). We will describe the performance of a selection model that combines both symptoms, patient characteristics and FIT to detect advanced neoplasia by defining its negative predictive value, positive predictive value, sensitivity and specificity. We will also describe the performance of FIT for different cut-off values by the above mentioned test characteristics.

Contacts

Public ContactManon Spaander

Erasmus MC

v.spaander@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)