Implementation of colorectal cancer screening with Faecal Occult Blood Test (FOBT) in the Netherlands

ISRCTN ISRCTN57917442
DOI https://doi.org/10.1186/ISRCTN57917442
Secondary identifying numbers CRC01
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
21/12/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr L.G.M van Rossum
Scientific

Radboud University Nijmegen Medical Centre
Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands

Phone +31 (0)24 361 7272
Email L.vanRossum@mdl.umcn.nl

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeQuality of life
Scientific title
Study acronymFOCUS
Study objectivesImplementation 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.
Ethics approval(s)Ethics approval received from the Dutch Health Council on the 3rd November 2005 (ref: 2005/03WBO).
Health condition(s) or problem(s) studiedColorectal cancer screening with Faecal Occult Blood Test (FOBT)
Intervention1. 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
Intervention typeOther
Primary outcome measureResponse rate per FOBT, measured at T2.
Secondary outcome measures1. Positivity rate, measured at T4
2. Detection rate, measured at T6
3. Positive predictive value, measured at T6
4. Specificity, measured at T6
Overall study start date01/05/2006
Completion date01/05/2016

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participants20000
Key inclusion criteriaMen and women 50 to 75 years of age.
Key exclusion criteriaLiving in an institution or similar.
Date of first enrolment01/05/2006
Date of final enrolment01/05/2016

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands

Sponsor information

University Medical Centre St. Radboud (The Netherlands)
Hospital/treatment centre

Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands

Website http://www.umcn.nl/homepage
ROR logo "ROR" https://ror.org/05wg1m734

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/08/2009 Yes No
Results article patient perspective results 01/11/2010 Yes No
Results article cost effectiveness results 15/04/2011 Yes No
Results article results 01/07/2011 Yes No