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
Protocol serial number	CRC02; NTR1010
Sponsor	University Medical Centre St. Radboud (Netherlands)
Funder	Radboud Universitair Medisch Centrum

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

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

Primary study design	Interventional
Study design	Randomised active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Study type	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(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/09/2017

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes