Condition category
Cancer
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.colonca.nl

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

CRC01

Study information

Scientific title

Acronym

FOCUS

Study hypothesis

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

Ethics approval received from the Dutch Health Council on the 3rd November 2005 (ref: 2005/03WBO).

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2006

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women 50 to 75 years of age.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

20000

Participant exclusion criteria

Living in an institution or similar.

Recruitment start date

01/05/2006

Recruitment end date

01/05/2016

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 (The 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

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19408302
2. 2011 patient perspective results in http://www.ncbi.nlm.nih.gov/pubmed/20560814
3. 2011 cost effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/20589677
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21367600

Publication citations

  1. Results

    van Rossum LG, van Rijn AF, van Oijen MG, Fockens P, Laheij RJ, Verbeek AL, Jansen JB, Dekker E, False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening., Int. J. Cancer, 2009, 125, 4, 746-750, doi: 10.1002/ijc.24458.

  2. Patient perspective results

    Deutekom M, van Rossum LG, van Rijn AF, Laheij RJ, Fockens P, Bossuyt PM, Dekker E, Jansen JB, Comparison of guaiac and immunological fecal occult blood tests in colorectal cancer screening: the patient perspective., Scand. J. Gastroenterol., 2010, 45, 11, 1345-1349, doi: 10.3109/00365521.2010.497937.

  3. Cost effectiveness results

    van Rossum LG, van Rijn AF, Verbeek AL, van Oijen MG, Laheij RJ, Fockens P, Jansen JB, Adang EM, Dekker E, Colorectal cancer screening comparing no screening, immunochemical and guaiac fecal occult blood tests: a cost-effectiveness analysis., Int. J. Cancer, 2011, 128, 8, 1908-1917, doi: 10.1002/ijc.25530.

  4. Results

    Dekker N, van Rossum LG, Van Vugt-van Pinxteren M, van Stiphout SH, Hermens RP, van Zelst-Stams WA, van Oijen MG, Laheij RJ, Jansen JB, Hoogerbrugge N, Adding familial risk assessment to faecal occult blood test can increase the effectiveness of population-based colorectal cancer screening., Eur. J. Cancer, 2011, 47, 10, 1571-1577, doi: 10.1016/j.ejca.2011.01.022.

Additional files

Editorial Notes