Early diagnosis of colorectal cancer by faecal occult blood detection - the Goteborg trial

ISRCTN ISRCTN58825135
DOI https://doi.org/10.1186/ISRCTN58825135
Secondary identifying numbers N/A
Submission date
16/08/2007
Registration date
11/09/2007
Last edited
11/09/2007
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

Prof Eva Haglind
Scientific

Bruna Straket 11B
Sahlgrenska University Hospital
Goteborg
SE 413 45
Sweden

Phone +46 (0)31 3426096
Email eva.haglind@vgregion.se

Study information

Study designRandomised, controlled, single centre, population based, interventional trial; control group not invited for screening.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific title
Study objectivesBy detection of early stages of colorectal tumours in the "healthy population", mortality from colorectal cancer is reduced.

Underlying this hypothesis is a further hypothesis that colorectal tumours develop over a time sequence, probably several years, from benign adenomas through localised cancer to cancer with spread growth, and that tumours in this sequence of development can be detected before they give symptoms observed by the individual.
Ethics approval(s)Approval received from the ethical committee of Goteborg University, Goteborg (Sweden) in 1982 (ref: 21-82).
Health condition(s) or problem(s) studiedColorectal cancer
InterventionIntervention: detection of faecal blood by Haemoccult analyses of samples from three consecutive stools, in the group randomised to "screening"
Control: no contact/information

If blood was detected, there was a continued intervention involving consultation with colorectal surgeon, sigmoidoscopy (60 cm) and barium enema. If found at sigmoidoscopy, adenomas were removed. If cancer/suspected cancer found at either investigation, surgery was followed at earliest possible date.

Total duration of follow-up was 11 - 19 years, mean of 15 years.
Intervention typeOther
Primary outcome measureMortality in colorectal cancer.

Time points were: after invitation, after screening participation, after work-up of positive screen test and after treatment for patients with positive work-up.
Secondary outcome measures1. Overall mortality
2. Quality of life
3. Sensitivity and specificity of screening procedure
4. Sensitivity and specificity of work up procedure
5. Stage distribution of adenomas and cancers

The questionnaires used were specifically designed for this trial, with face validation and tested in pilot populations before use. Time points were: after invitation, after screening participation, after work-up of positive screen test and after treatment for patients with positive work-up.
Overall study start date01/09/1982
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants68,000
Key inclusion criteriaThe entire population was born between 1918 and 1931, men and women, in Goteborg, Sweden. Only those randomised to "intervention, i.e., screening for occult faecal blood" were invited to participate, the control group was not contacted. Initial invitation to the trial was when each individual was between the ages of 60 to 64 years, thus inclusion from 1982 to 1995 in cohorts of five years.
Key exclusion criteriaDoes not meet the above criteria.
Date of first enrolment01/09/1982
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Sweden

Study participating centre

Bruna Straket 11B
Goteborg
SE 413 45
Sweden

Sponsor information

Swedish Cancer Society (Sweden)
Research organisation

David Bagares Gata 5
Stockholm
SE 101 55
Sweden

Phone +46 (0)8 6771000
Email info@cancerfonden.se
Website http://www.cancerfonden.se
ROR logo "ROR" https://ror.org/0527jb766

Funders

Funder type

Charity

Swedish Cancer Society (Sweden)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Swedish Cancer Society
Location
Sweden
Assar Gabrielsson Foundation (Sweden)

No information available

Goteborgs Lakarsallskap, Inga-Britt and Arne Lundberg Research Foundation (Sweden)

No information available

Magnus Bergvall Foundation (Sweden)

No information available

Gunnar and Elisabeth Nilsson Foundation (Sweden)

No information available

Jubileumsklinikens Foundation (Sweden)

No information available

Sahlgrenska University Hospital Foundation (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications 01/12/1986 Yes No
Other publications 01/12/1987 Yes No
Other publications 01/08/1988 Yes No
Other publications 01/03/1989 Yes No
Other publications 01/03/1990 Yes No
Other publications . 01/12/1990 Yes No
Other publications . 12/06/1991 Yes No
Other publications . 01/10/1992 Yes No
Other publications 01/02/1994 Yes No
Other publications 01/05/1994 Yes No
Other publications . 01/02/1995 Yes No
Other publications . 01/02/1995 Yes No
Other publications 01/06/1996 Yes No
Other publications 01/03/1997 Yes No