There is no difference in test performance between the OC-sensor and FOB-Gold in a 4th round of FIT-screening.
ID
Bron
Aandoening
FIT, screening, colorectal cancer, advanced neoplasia, bevolkingsonderzoek darmkanker, FOBT
Ondersteuning
Erasmus Medical Center
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Participation, positivity rate, diagnostic yield and practical use for two types of FITs (OC-Sensor and FOB-Gold)
Achtergrond van het onderzoek
Colorectal cancer (CRC) is one of the major causes of death in the Netherlands, accounting for over 5100 deaths in 2010.
Population screening aims to detect CRC in an earlier phase, thereby reducing CRC morbidity and mortality. In the Netherlands, population screening for CRC is currently being implemented based on biennial testing with a single, quantitative fecal immunochemical test (FIT, i.e. immunochemical FOBT). Whereas several FITs are available on the market, all pilot-studies in our country were performed with the OC-Sensor test (Eiken, Japan). The tender for the nationwide program however, has been allocated to another FIT: the FOB-Gold (Sentinel,Italy). Only sparse data on screening with the FOB-Gold are available without a head-to-head comparison between FOB-Gold and OC-Sensor regarding participation rates, test characteristics and practical use. We plan a randomized controlled trial for a 4th round of biennial FIT-screening in the combined dynamic cohorts of Amsterdam and Rijnmond, consisting of approximately 22.000 persons aged 50-75. Invitees will be randomized to receive either the OC-Sensor or the FOB-Gold FIT. The cut-off level for positivity of both tests will be the lowest level that is technically achievable, enabling comparison and modeling for different cut-off levels. All persons with a positive test-result will be referred for colonoscopy. Primary outcome will differences between the two types of FIT for participation, positivity rate, diagnostic yield and practical use.
Doel van het onderzoek
There is no difference in test performance between the OC-sensor and FOB-Gold in a 4th round of FIT-screening.
Onderzoeksopzet
n.a.
Onderzoeksproduct en/of interventie
n.a.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Average risk persons aged 50-75 years old in the Amsterdam and Rijnmond region. We will
invite all persons from the dynamic cohort of approximately 22.000 persons that were invited in the previous rounds and were
originally recruited by random selection in the city population database (Gemeentelijke Basis Administratie, GBA).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria for colonoscopy are: complete colonoscopy or CT-colonography performed within the last 2 years; severe
co-morbidity (ASA IV/V); terminal disease (life-expectancy < 5 years); inability or refusal to provide informed consent.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5278 |
| NTR-old | NTR5385 |
| Ander register | WBO: 161536-112008-PG : ZonMw: 50-51515-98-302 |