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Implementation of colorectal cancer screening with Faecal Occult Blood Test (FOBT) in the Netherlands
ISRCTN ISRCTN57917442
DOI 10.1186/ISRCTN57917442
ClinicalTrials.gov identifier
EudraCT number
Public title Implementation of colorectal cancer screening with Faecal Occult Blood Test (FOBT) in the Netherlands
Scientific title
Acronym FOCUS
Serial number at source CRC01
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Dutch Health Council on the 3rd November 2005 (ref: 2005/03WBO).
Study design Multicentre, randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Colorectal cancer screening with Faecal Occult Blood Test (FOBT)
Participants - inclusion criteria Men and women 50 to 75 years of age.
Participants - exclusion criteria Living in an institution or similar.
Anticipated start date 01/05/2006
Anticipated end date 01/05/2016
Status of trial Ongoing
Patient information material
Target number of participants 20000
Interventions 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
Primary outcome measure(s) Response rate per FOBT, measured at T2.
Secondary outcome measure(s) 1. Positivity rate, measured at T4
2. Detection rate, measured at T6
3. Positive predictive value, measured at T6
4. Specificity, measured at T6
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website http://www.colonca.nl
Publications 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19408302
2. 2011 patient perspective results in http://www.ncbi.nlm.nih.gov/pubmed/20560814
3. 2011 cost effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/20589677
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21367600
Contact name Dr  L.G.M  van Rossum
  Address Radboud University Nijmegen Medical Centre
Department of Gastroenterology and Hepatology
  City/town Nijmegen
  Zip/Postcode 6500 HB
  Country Netherlands
  Tel +31 (0)24 361 7272
  Fax +31 (0)24 354 0103
  Email L.vanRossum@mdl.umcn.nl
Sponsor University Medical Centre St. Radboud (The Netherlands)
  Address Department of Gastroenterology and Hepatology
  City/town Nijmegen
  Zip/Postcode 6500 HB
  Country Netherlands
  Sponsor website: http://www.umcn.nl/homepage
Date applied 23/08/2007
Last edited 21/12/2011
Date ISRCTN assigned 23/08/2007
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