Early diagnosis of colorectal cancer by faecal occult blood detection - the Goteborg trial
ISRCTN | ISRCTN58825135 |
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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
Scientific
Bruna Straket 11B
Sahlgrenska University Hospital
Goteborg
SE 413 45
Sweden
Phone | +46 (0)31 3426096 |
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eva.haglind@vgregion.se |
Study information
Study design | Randomised, controlled, single centre, population based, interventional trial; control group not invited for screening. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
Scientific title | |
Study objectives | By 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) studied | Colorectal cancer |
Intervention | Intervention: 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 type | Other |
Primary outcome measure | Mortality 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 measures | 1. 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 date | 01/09/1982 |
Completion date | 31/12/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 68,000 |
Key inclusion criteria | The 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 criteria | Does not meet the above criteria. |
Date of first enrolment | 01/09/1982 |
Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Bruna Straket 11B
Goteborg
SE 413 45
Sweden
SE 413 45
Sweden
Sponsor information
Swedish Cancer Society (Sweden)
Research organisation
Research organisation
David Bagares Gata 5
Stockholm
SE 101 55
Sweden
Phone | +46 (0)8 6771000 |
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info@cancerfonden.se | |
Website | http://www.cancerfonden.se |
https://ror.org/0527jb766 |
Funders
Funder type
Charity
Swedish Cancer Society (Sweden)
Private sector organisation / Trusts, charities, foundations (both public and private)
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |