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
CRC02; NTR1010
Study information
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
Acronym
SONOS
Study hypothesis
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
Ethics approval provisionally received from the Dutch Health Council, 03/11/2005, ref: 2005/03WBO
Study design
Randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2007
Overall trial end date
01/09/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women 50 to 75 years of age
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
20000
Participant exclusion criteria
Living in an institution or similar
Recruitment start date
01/09/2007
Recruitment end date
01/09/2017
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 (Netherlands)
Sponsor details
Department of Gastroenterology and Hepatology
Nijmegen
6500 HB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud Universitair Medisch Centrum
Alternative name(s)
Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
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