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van CCT (UK)

van CCT (UK)

Two-sample FIT-screening: a 4th screening round

- candidate number24095
- NTR NumberNTR5740
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2016
- Secondary IDs161536-112008-PG WBO
- Public TitleTwo-sample FIT-screening: a 4th screening round
- Scientific TitleFourth round of two-sample fecal immunochemical test screening for colorectal cancer in the Netherlands
- hypothesis
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Screening
- Inclusion criteriaAverage risk persons aged 50-75 years old in the Rotterdam-Rijnmond region. We will invite all persons from the dynamic cohort of approximately 3200 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 trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-feb-2016
- Target number of participants3197
- InterventionsPeople will receive two identical FITs (OC-sensor, Eiken Japan) to sample from two consecutive bowel movements.
- Primary outcomeParticipation, positivity rate, diagnostic yield of two-sample FIT screening.
- Secondary outcomeParticipation-rate and diagnostic yield of a 4th round of biennial two-sample FIT-screening compared to previous rounds. Impact of repeated biennial two-sample 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. Comparison of outcomes with paralell one-sample FIT screening cohort.
- Timepointsn.a.
- Trial web
- statusinclusion stopped: follow-up
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- 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. Long-term randomized prospective trials using guaiac-based fecal occult blood testing (gFOBT) have proven to decrease CRC related mortality. Currently the classical gFOBT is being replaced by the fecal immunochemical test (FIT), as FIT is more specific to lower-digestive tract blood loss and leads to higher participation and detection rate. While gFOBT samples on multiple consecutive bowel movements, standard FIT only uses one sample from one bowel movement. Since advanced neoplasia can bleed intermittently, it may be missed with single stool sampling. Screening by means of a 2-sample FIT can reduce the risk of missing advanced lesions, and therefore increase test sensitivity. People aged 50-75 years will receive two identical FITs (OC-sensor, Eiken Japan) to sample from two consecutive bowel movements.
The cut-off level for positivity will be 10 g hemoglobin per gram feces, which is the lowest level used worldwide, enabling comparison and modeling for different cut-off levels. Participants with at least one positive test will be offered colonoscopy.
We aim to determine participaton and diagnostic yield of repeated 2-sample FIT screening. We will also compare these data with repeated 1-sample FIT screening to assess the additional yield of 2-sample FIT screening to current screening strategies. We will focus on cumulative yield after four rounds, as well as comparing yield per round. These data will give us insight in alternative screening strategies and provides the opportunity to optimize implementation of the nation-wide colorectal cancer screening program.
- Main changes (audit trail)
- RECORD11-mrt-2016 - 22-mei-2016

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