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ISRCTN
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ISRCTN57917442
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ClinicalTrials.gov identifier
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Public title
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Implementation of colorectal cancer screening with Faecal Occult Blood Test (FOBT) in the Netherlands
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Scientific title
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Acronym
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FOCUS
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Serial number at source
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CRC01
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Study hypothesis
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Implementation of colorectal cancer screening with Faecal Occult Blood Test (FOBT) in the Netherlands is feasible.
Please note that the follow-up study to this randomised controlled trial can be found at ISRCTN94861265: Screening Or NO Screening: differences in survival during follow-up after random colorectal cancer screening with faecal occult blood test or no screening.
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Ethics approval
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Ethics approval received from the Dutch Health Council on the 3rd November 2005 (ref: 2005/03WBO).
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Study design
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Multicentre, randomised, active controlled, parallel group trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Colorectal cancer screening with Faecal Occult Blood Test (FOBT)
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Participants - inclusion criteria
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Men and women 50 to 75 years of age.
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Participants - exclusion criteria
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Living in an institution or similar.
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Anticipated start date
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01/05/2006
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Anticipated end date
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01/05/2016
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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20000
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Interventions
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1. Invitation by information of municipal database versus general practitioner database
2. Faecal Occult Blood Test (FOBT): Guaiac-FOBT versus Immunochemical FOBT one day or two day testing
3. If FOBT positive: colonoscopy
Timepoints:
T0 = randomisation
T1 = invitation of the individuals randomised to the screening group
T2 = receive date of the test
T3 = evaluation date of the test in the laboratory
T4 = positive (including invitation for pre-colonoscopy consultation) or negative result letter
T5 = pre-colonoscopy consultation
T6 = colonoscopy
T7 = further treatment if necessary
T8 = start follow-up (for no screening group T8 starts immediately, for the screening group with negative test T8 is consecutive after T3)
T9 = follow-up 1 year
T10 = follow-up 2 years
T11 = follow-up 3 years
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Primary outcome measure(s)
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Response rate per FOBT, measured at T2.
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Secondary outcome measure(s)
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1. Positivity rate, measured at T4
2. Detection rate, measured at T6
3. Positive predictive value, measured at T6
4. Specificity, measured at T6
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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http://www.colonca.nl
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Publications
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1. results in http://www.ncbi.nlm.nih.gov/pubmed/19408302
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Contact name
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Dr
L.G.M
van Rossum
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Address
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Radboud University Nijmegen Medical Centre
Department of Gastroenterology and Hepatology
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Tel
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+31 (0)24 361 7272
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Fax
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+31 (0)24 354 0103
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Email
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L.vanRossum@mdl.umcn.nl
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Sponsor
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University Medical Centre St. Radboud (The Netherlands)
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Address
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Department of Gastroenterology and Hepatology
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Sponsor website:
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http://www.umcn.nl/homepage
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Date applied
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23/08/2007
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Last edited
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30/06/2009
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Date ISRCTN assigned
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23/08/2007
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