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

ISRCTN	ISRCTN58825135
DOI	https://doi.org/10.1186/ISRCTN58825135
Protocol serial number	N/A
Sponsor	Swedish Cancer Society (Sweden)
Funders	Swedish Cancer Society (Sweden), Assar Gabrielsson Foundation (Sweden), Goteborgs Lakarsallskap, Inga-Britt and Arne Lundberg Research Foundation (Sweden), Magnus Bergvall Foundation (Sweden), Gunnar and Elisabeth Nilsson Foundation (Sweden), Jubileumsklinikens Foundation (Sweden), Sahlgrenska University Hospital Foundation (Sweden)

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

Primary study design	Interventional
Study design	Randomised, controlled, single centre, population based, interventional trial; control group not invited for screening.
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	68000
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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