Comparison study of two fecal immunochemical tests within a nationwide colorectal cancer screening program

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26021

Enrollment

44038

Registered

2016-05-27

Start date

2016-05-15

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

screening, colorectal cancer

Interventions

Screenees will receive two FITs (OC-sensor, Eiken Japan and FOB-Gold, Sentinel) to sample from one bowel movement.

Eligibility

Inclusion criteria

Inclusion criteria: Average risk persons aged 55-75 years old in the South-West region. We will invite all persons from the national screening program in this region, who are recruited by random selection from the nationwide screening database.

Exclusion criteria

Exclusion criteria: Exclusion criteria for colonoscopy are: underwent proctocolectomy; is currently treated for colorectal cancer; is currently treated for IBD; terminal disease (life-expectancy < 5 years); inability or refusal to provide informed consent.

Design outcomes

Primary

Measure	Time frame
detection rate of advanced neoplasia	—

Secondary

Measure	Time frame
Participation, positivity rate, diagnostic yield of FIT screening, relative sensitivity.	—

Contacts

Public ContactM.C.W. Spaander

Erasmus Medical Center Rotterdam

v.spaander@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)