Condition category
Cancer
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
01/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcn.nl/homepage

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

Publication citations

Additional files

Editorial Notes