Mobiele menu

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

Projectomschrijving

Verschillende proeven getest in proefbevolkingsonderzoek darmkanker

Vraagstuk

Voor het bevolkingsonderzoek naar darmkanker zijn verschillende proeven beschikbaar. Om de juiste keuze te maken, is gedurende de proeffase een wetenschappelijke studie opgezet om de bruikbaarheid en effectiviteit van diverse testmethoden na te gaan. De resultaten maken het mede mogelijk om het effect van screening over een langere periode te evalueren. En om het bevolkingsonderzoek te verbeteren.

Onderzoek

In de vierde ronde van het proefbevolkingsonderzoek darmkanker zijn twee verschillende typen ontlastingstesten met elkaar vergeleken: OC Sensor (bij 9.669 mensen) en FOB Gold (bij 9.622 mensen).

Uitkomst

In het onderzoek bleek 63% van de genodigden aan het proefbevolkingsonderzoek mee te doen. Er was geen verschil tussen de twee testen. Bij aankomst op het laboratorium bleek de FOB Gold echter vaker niet goed te analyseren te zijn, waardoor er meer personen nogmaals een test toegestuurd moesten krijgen. Met beide testen werden evenveel grote of onrustige (‘geavanceerde’) poliepen en darmkanker opgespoord.

Producten

Titel: Results of the fourth round of screening
Auteur: M. van der Vlugt, E. Dekker
Titel: Comparison of colonoscopy, sigmoidoscopy and multiple rounds of FIT-based colorectal cancer screening: long-term follow-up.
Auteur: E.J. Grobbee1, M. van der Vlugt, A.J. van Vuuren, A.K. Stroobants, RC Mallant-Hent, I. Lansdorp-Vogelaar, P.M.M. Bossuyt, E.J. Kuipers, E. Dekker, M.C.W. Spaander
Titel: Comparison of colonoscopy, sigmoidoscopy and multiple rounds of FIT-based colorectal cancer screening: long-term follow-up.
Auteur: E.J. Grobbee1, M. van der Vlugt, A.J. van Vuuren, A.K. Stroobants, RC Mallant-Hent, I. Lansdorp-Vogelaar, P.M.M. Bossuyt, E.J. Kuipers, E. Dekker, M.C.W. Spaander
Titel: Adherence to colorectal cancer screening: 4 rounds of fecal immunochemical test based screening.
Auteur: Manon van der Vlugt, Esmée J. Grobbee, Patrick M.M. Bossuyt, Ernst J. Kuipers, Iris Lansdorp-Vogelaar, Marie-Louise Essink-Bot, Manon C.W. Spaander, Evelien Dekker.
Titel: Screen-detected and non-screen-detected colorectal cancers after four rounds of fecal immunochemical test-based colorectal cancer screening
Auteur: Manon van der Vlugt, Esmée J. Grobbee, Patrick M. Bossuyt, Amanda C.R.K. Bos, Iris Lansdorp-Vogelaar, Manon C.W. Spaander, Evelien Dekker.
Titel: Comparison of OC-sensor and FOB-Gold in population-based colorectal cancer screening based on FIT.
Auteur: Grobbee E, van der Vlugt M, A.J. van Vuuren, A.K. Stroobants, M. Mundt, W.J. Spijker, E. Bongers, E.J.Kuipers, I. Lansdorp-Vogelaar, P.M. Bossuyt, E. Dekker, M.C.W. Spaander
Titel: Adherence to colorectal cancer screening: 4 rounds of fecal immunochemical test (FIT) based screening.
Auteur: Manon van der Vlugt, Esmée J. Grobbee, Patrick M.M. Bossuyt, Ernst J. Kuipers, Iris Lansdorp-Vogelaar, Marie-Louise Essink-Bot, Manon C.W. Spaander, Evelien Dekker.
Titel: Screen-detected and non-screen-detected colorectal cancers after four rounds of fecal immunochemical test-based colorectal cancer screening.
Auteur: Manon van der Vlugt, Esmée J. Grobbee, Patrick M. Bossuyt, Amanda C.R.K. Bos, Iris Lansdorp-Vogelaar, Manon C.W. Spaander, Evelien Dekker.
Titel: Comparison of OC-sensor and FOB-Gold in population-based colorectal cancer screening based on FIT.
Auteur: Grobbee E, van der Vlugt M, A.J. van Vuuren, A.K. Stroobants, M. Mundt, W.J. Spijker, E. Bongers, E.J.Kuipers, I. Lansdorp-Vogelaar, P.M. Bossuyt, E. Dekker, M.C.W. Spaander
Titel: Comparison of colonoscopy, sigmoidoscopy and multiple rounds of FIT-based colorectal cancer screening: long-term follow-up
Auteur: E.J. Grobbee1, M. van der Vlugt, A.J. van Vuuren, A.K. Stroobants, RC Mallant-Hent, I. Lansdorp-Vogelaar, P.M.M. Bossuyt, E.J. Kuipers, E. Dekker, M.C.W. Spaander
Titel: A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening
Auteur: Grobbee, E J, van der Vlugt, M, van Vuuren, A J, Stroobants, A K, Mundt, M W, Spijker, W J, Bongers, E J C, Kuipers, E J, Lansdorp-Vogelaar, I, Bossuyt, P M, Dekker, E, Spaander, M C W
Magazine: Gut
Titel: Adherence to colorectal cancer screening: four rounds of faecal immunochemical test-based screening
Auteur: van der Vlugt, Manon, Grobbee, Esmée J, Bossuyt, Patrick MM, Bongers, Evelien, Spijker, Wolfert, Kuipers, Ernst J, Lansdorp-Vogelaar, Iris, Essink-Bot, Marie-Louise, Spaander, Manon C W, Dekker, Evelien
Magazine: British Journal of Cancer
Titel: Interval Colorectal Cancer Incidence Among Subjects Undergoing Multiple Rounds of Fecal Immunochemical Testing
Auteur: Manon van der Vlugt, Esmée J. Grobbee, Patrick M.M. Bossuyt, Amanda Bos, Evelien Bongers, Wolfert Spijker, Ernst J kuipers, Iris Lansdorp-Vogelaar, Manon C.W. Spaander, Evelien Dekker
Magazine: Gastroenterology
Titel: Population-based colorectal screening by fecal immunochemical testing over multiple rounds
Auteur: Manon van der Vlugt

Verslagen


Samenvatting van de aanvraag

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. Of the currently available screening tests, fecal occult blood tests (FOBT) and sigmoidoscopy are the only strategies with documented efficacy in RCTs. Individuals with a positive FOBT are referred for colonoscopy, the current reference standard for the detection of colorectal cancer and its precursor lesions, adenomas. FOBT-based screening can only be effective with good adherence to colonoscopy among FOBT-positive individuals. In the Netherlands, population screening for CRC will be gradually implemented from January 2014 onwards based on biennial testing with a single, quantitative fecal immunochemical test (FIT, i.e. immunochemical FOBT. This nationwide program is based on the results of two pilot-programs in the regions of Amsterdam and Rijnmond. However, to determine the eventual impact of a continuous biennial FIT-screening program, long-term data should be obtained. The combined pilot-cohorts in Amsterdam and Rijnmond comprise in total approximately 22.000 persons that have been followed for 7 years. Following this ‘forerunner-group’ by continuing biennial FIT-screening would enable us to obtain data over more screening rounds, anticipating the future results of nationwide implementation. Besides the importance of predicting the cost-efficacy of the nationwide program, these data are also of key relevance for planning of capacity for intakes and colonoscopies of FIT-positives. 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). The FOB-Gold test will be implemented with a cutoff level of 15 microgram Hb/gram feces. 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. Therefore, these data as well as data on specific test-characteristics (including positivity-rate, positive predictive value at different cut-off values) in the population setting should be obtained. 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. Persons with a previous positive test will be excluded. 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 invited for a consultation at the outpatient clinic and will be recommended a follow-up colonoscopy. Primary outcome measures are: 1) differences between the two types of FIT for participation, positivity rate, diagnostic yield and practical use, 2) participation-rate and diagnostic yield of a 4th round of biennial FIT-screening compared to previous rounds, 3) the number of interval-cancers in participants and non-participants of repeated rounds. The long-term effect on incidence and mortality of CRC of a nationwide FIT-based screening program in the Netherlands will be estimated by use of the data of 4 rounds of FIT-screening in the MISCAN-model.

Onderwerpen

Kenmerken

Projectnummer:
200340001
Looptijd: 100%
Looptijd: 100 %
2013
2017
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
Prof. dr. E. Dekker
Verantwoordelijke organisatie:
Amsterdam UMC - locatie AMC