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
Contact information
Dr L.G.M van Rossum
Scientific
Scientific
Radboud University Nijmegen Medical Centre
Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 361 7272 |
|---|---|
| L.vanRossum@mdl.umcn.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | FOCUS |
| Study objectives | 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(s) | Ethics approval received from the Dutch Health Council on the 3rd November 2005 (ref: 2005/03WBO). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2006 |
| Completion date | 01/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 20000 |
| Key inclusion criteria | Men and women 50 to 75 years of age. |
| Key exclusion criteria | Living in an institution or similar. |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/05/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
University Medical Centre St. Radboud (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands
| Website | http://www.umcn.nl/homepage |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
