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van CCT (UK)

van CCT (UK)

Various aspects of FIT-screening: a 4th screening round.

- candidate number22542
- NTR NumberNTR5385
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-aug-2015
- Secondary IDsZonMw: 50-51515-98-302 WBO: 161536-112008-PG
- Public TitleVarious aspects of FIT-screening: a 4th screening round.
- Scientific TitleVarious aspects of FIT-screening: a 4th screening round.
- hypothesisThere is no difference in test performance between the OC-sensor and FOB-Gold in a 4th round of FIT-screening.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Screening
- Inclusion criteriaAverage 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).
- Exclusion criteriaExclusion 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-mei-2015
- Target number of participants20000
- Interventionsn.a.
- Primary outcomeParticipation, positivity rate, diagnostic yield and practical use for two types of FITs (OC-Sensor and FOB-Gold)
- Secondary outcomeParticipation-rate and diagnostic yield of a 4th round of biennial FIT-screening compared to previous rounds. Impact of repeated biennial FIT-screening on participation-rates (per round, in consecutive rounds and per program), as well as the yield and occurrence of interval cancers in participants and non-participants of repeated rounds.
- Timepointsn.a.
- Trial web
- statusinclusion stopped: follow-up
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsn.a.
- Brief summaryColorectal 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.
- Main changes (audit trail)
- RECORD6-aug-2015 - 17-okt-2015

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