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van CCT (UK)

van CCT (UK)

Implementation of Colorectal Cancer Screening with FOBT in the Netherlands.

- candidate number2639
- NTR NumberNTR1006
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR27-jun-2007
- Secondary IDsCRC01 
- Public TitleImplementation of Colorectal Cancer Screening with FOBT in the Netherlands.
- Scientific TitleImplementation of Colorectal Cancer Screening with FOBT in the Netherlands.
- hypothesisImplementation of Colorectal Cancer Screening with FOBT in the Netherlands is feasible
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Mass screening, Occult bleeding, Response rate
- Inclusion criteriaMen and women 50-75 years of age
- Exclusion criteriaLiving in an institution or similar
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-mei-2016
- Target number of participants20000
- Interventions1. Invitation by information of municipal database versus general practioner database 2. Fecal Occult Blood Test (FOBT) Guaiac-FOBT versus Immunochemical FOBT one day or two day testing 3. If FOBT positive: Colonoscopy
- Primary outcomeResponse rate per FOBT
- Secondary outcome1. Positivity rate 2. Detection rate 3. Positive predictive value 4. Specificity
- Timepoints
- Trial web site;
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Centre St. Radboud, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryColorectal cancer (CRC) morbidity and mortality generates a major health problem. CRC morbidity and mortality can be reduced by screening and should be implemented according to the European Community. At present evidence indicates that fecal occult blood testing is the screening method of choice, but many issues essential to a well organized screening program are still unanswered. One of the major concerns is the sometimes extremely low response to, and compliance rate of CRC screening programs in many countries. The primary aim of this study is to assess the response to the screening protocol under different conditions. In addition it will be examined how response to the screening protocol can be optimized. Furthermore, feasibility and organizational logistics and some cost-effectiveness issues of CRC screening will be investigated. A representative sample of the Dutch population consisting of 20,000 asymptomatic average risk subjects in the age-group of 50-74 years, from the Nijmegen and Amsterdam area, will be invited to participate. All prospective subjects will receive a general information leaflet about CRC-screening, a risk assessment questionnaire and a FOBT. The subjects will be randomized to receive either a FOBT-kit based on a guaiac or an immunochemical testing method. If the FOBT turns out to be positive or the questionnaire indicates an elevated risk, subjects will be invited for colonoscopy. Each subject will also receive a questionnaire to study quality of life. Reasons for non-response will finally be evaluated by a telephone questionnaire. The project will be implemented in screening centers affiliated to University Medical Center Nijmegen (UMCN) and to Amsterdam University Medical Center (AMC), in collaboration with the Comprehensive Cancer Centers in Nijmegen (IKO) and Amsterdam (IKA). The results will facilitate the decision whether or not to implement nation-wide CRC screening in the Netherlands. In the light of our previous and current commitment and investments, we are obliged to participate in future extensions of the study, for example extension of the FOBT-screening method with other procedures, such as sigmoidoscopy, colonoscopy, double-contrast barium enema or CT-colonography.
- Main changes (audit trail)
- RECORD27-jun-2007 - 13-nov-2008

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