Screening Or NO Screening: differences in survival during follow-up after random colorectal cancer screening with faecal occult blood test or no screening
| ISRCTN | ISRCTN94861265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94861265 |
| Secondary identifying numbers | CRC02; NTR1010 |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 01/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 | Randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Screening Or NO Screening: differences in survival during follow-up after random colorectal cancer screening with faecal occult blood test or no screening |
| Study acronym | SONOS |
| Study objectives | Survival after screening for colorectal cancer with faecal occult blood test is increased compared with no screening. Please note that this is the follow-up trial to ISRCTN57917442: Implementation of colorectal cancer screening with Faecal Occult Blood Test (FOBT) in the Netherlands. |
| Ethics approval(s) | Ethics approval provisionally received from the Dutch Health Council, 03/11/2005, ref: 2005/03WBO |
| Health condition(s) or problem(s) studied | Colorectal cancer screening with Faecal Occult Blood Test (FOBT) |
| Intervention | Faecal occult blood test versus no test. Timepoints (included in original trial - see hypothesis): 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 | Survival In each year of the follow-up (timepoints T9 - T11), the population will be censored for: 1. Mortality of colorectal cancer 2. Mortality of other causes 3. Other reasons for loss to follow-up |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/09/2007 |
| Completion date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| 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 | 01/09/2007 |
| Date of final enrolment | 01/09/2017 |
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 (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
Hospital/treatment centre
Radboud Universitair Medisch Centrum
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
- Location
- Netherlands
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 |
