Contact information
Type
Scientific
Primary contact
Dr L.G.M van Rossum
ORCID ID
Contact details
Radboud University Nijmegen Medical Centre
Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 7272
L.vanRossum@mdl.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CRC01
Study information
Scientific title
Acronym
FOCUS
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Colorectal cancer screening with Faecal Occult Blood Test (FOBT)
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Response rate per FOBT, measured at T2.
Secondary outcome measures
1. Positivity rate, measured at T4
2. Detection rate, measured at T6
3. Positive predictive value, measured at T6
4. Specificity, measured at T6
Overall trial start date
01/05/2006
Overall trial end date
01/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women 50 to 75 years of age.
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
20000
Participant exclusion criteria
Living in an institution or similar.
Recruitment start date
01/05/2006
Recruitment end date
01/05/2016
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
University Medical Centre St. Radboud (The Netherlands)
Sponsor details
Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
van Rossum LG, van Rijn AF, van Oijen MG, Fockens P, Laheij RJ, Verbeek AL, Jansen JB, Dekker E, False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening., Int. J. Cancer, 2009, 125, 4, 746-750, doi: 10.1002/ijc.24458.
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Patient perspective results
Deutekom M, van Rossum LG, van Rijn AF, Laheij RJ, Fockens P, Bossuyt PM, Dekker E, Jansen JB, Comparison of guaiac and immunological fecal occult blood tests in colorectal cancer screening: the patient perspective., Scand. J. Gastroenterol., 2010, 45, 11, 1345-1349, doi: 10.3109/00365521.2010.497937.
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Cost effectiveness results
van Rossum LG, van Rijn AF, Verbeek AL, van Oijen MG, Laheij RJ, Fockens P, Jansen JB, Adang EM, Dekker E, Colorectal cancer screening comparing no screening, immunochemical and guaiac fecal occult blood tests: a cost-effectiveness analysis., Int. J. Cancer, 2011, 128, 8, 1908-1917, doi: 10.1002/ijc.25530.
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Results
Dekker N, van Rossum LG, Van Vugt-van Pinxteren M, van Stiphout SH, Hermens RP, van Zelst-Stams WA, van Oijen MG, Laheij RJ, Jansen JB, Hoogerbrugge N, Adding familial risk assessment to faecal occult blood test can increase the effectiveness of population-based colorectal cancer screening., Eur. J. Cancer, 2011, 47, 10, 1571-1577, doi: 10.1016/j.ejca.2011.01.022.