Condition category
Cancer
Date applied
16/08/2007
Date assigned
11/09/2007
Last edited
11/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eva Haglind

ORCID ID

Contact details

Bruna Straket 11B
Sahlgrenska University Hospital
Goteborg
SE 413 45
Sweden
+46 (0)31 3426096
eva.haglind@vgregion.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Approval received from the ethical committee of Goteborg University, Goteborg (Sweden) in 1982 (ref: 21-82).

Study design

Randomised, controlled, single centre, population based, interventional trial; control group not invited for screening.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/1982

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

68,000

Participant exclusion criteria

Does not meet the above criteria.

Recruitment start date

01/09/1982

Recruitment end date

31/12/2001

Locations

Countries of recruitment

Sweden

Trial participating centre

Bruna Straket 11B
Goteborg
SE 413 45
Sweden

Sponsor information

Organisation

Swedish Cancer Society (Sweden)

Sponsor details

David Bagares Gata 5
Stockholm
SE 101 55
Sweden
+46 (0)8 6771000
info@cancerfonden.se

Sponsor type

Research organisation

Website

http://www.cancerfonden.se

Funders

Funder type

Charity

Funder name

Swedish Cancer Society (Sweden)

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Assar Gabrielsson Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Magnus Bergvall Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gunnar and Elisabeth Nilsson Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Jubileumsklinikens Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sahlgrenska University Hospital Foundation (Sweden)

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

Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=3292038
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=8036464
3. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=2720326
4. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=8306829
5. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=8646956
6. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=9085461
7. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=3790958
8. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=3792765
9. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=2322788
10. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=2056836
11. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=1439536
12. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=7732341
13. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=7601048
14. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=2276015

Publication citations

  1. Kewenter J, Björk S, Haglind E, Smith L, Svanvik J, Ahrén C, Screening and rescreening for colorectal cancer. A controlled trial of fecal occult blood testing in 27,700 subjects., Cancer, 1988, 62, 3, 645-651.

  2. Kewenter J, Brevinge H, Engarås B, Haglind E, Ahrén C, Results of screening, rescreening, and follow-up in a prospective randomized study for detection of colorectal cancer by fecal occult blood testing. Results for 68,308 subjects., Scand. J. Gastroenterol., 1994, 29, 5, 468-473.

  3. Kewenter J, Haglind E, Smith L, Value of a risk questionnaire in screening for colorectal neoplasm., Br J Surg, 1989, 76, 3, 280-283.

  4. Kewenter J, Brevinge H, Engarås B, Haglind E, Ahrén C, Follow-up after screening for colorectal neoplasms with fecal occult blood testing in a controlled trial., Dis. Colon Rectum, 1994, 37, 2, 115-119.

  5. Kewenter J, Brevinge H, Endoscopic and surgical complications of work-up in screening for colorectal cancer., Dis. Colon Rectum, 1996, 39, 6, 676-680.

  6. Lindholm E, Berglund B, Kewenter J, Haglind E, Worry associated with screening for colorectal carcinomas., Scand. J. Gastroenterol., 1997, 32, 3, 238-245.

  7. Jensen J, Kewenter J, Haglind E, Lycke G, Svensson C, Ahrén C, Diagnostic accuracy of double-contrast enema and rectosigmoidoscopy in connection with faecal occult blood testing for the detection of rectosigmoid neoplasms., Br J Surg, 1986, 73, 12, 961-964.

  8. Kewenter J, Jensen J, Boijsen M, Lycke G, Tylén U, Perception errors with double-contrast enema after a positive guaiac test., Gastrointest Radiol, 1987, 12, 1, 79-82, doi: 10.1007/BF01885109.

  9. Jensen J, Kewenter J, Asztély M, Lycke G, Wojciechowski J, Double contrast barium enema and flexible rectosigmoidoscopy: a reliable diagnostic combination for detection of colorectal neoplasm., Br J Surg, 1990, 77, 3, 270-272.

  10. Kewenter J, Asztély M, Engarås B, Jensen J, Haglind E, Ahrén C, [Double contrast colon radiography plus rectosigmoidoscopy. The combination method is necessary for the diagnosis of colorectal neoplasms]., Lakartidningen, 1991, 88, 24, 2229-2232.

  11. Jensen J, Kewenter J, Swedenborg J, The anatomic range of examination by fibreoptic rectosigmoidoscopy (60 centimetres)., Scand. J. Gastroenterol., 1992, 27, 10, 842-844.

  12. Lindholm E, Berglund B, Haglind E, Kewenter J, Factors associated with participation in screening for colorectal cancer with faecal occult blood testing., Scand. J. Gastroenterol., 1995, 30, 2, 171-176.

  13. Kewenter J, Brevinge H, Engarås B, Haglind E, The yield of flexible sigmoidoscopy and double-contrast barium enema in the diagnosis of neoplasms in the large bowel in patients with a positive Hemoccult test., Endoscopy, 1995, 27, 2, 159-163, doi: 10.1055/s-2007-1005655.

  14. Kewenter J, Engarås B, Haglind E, Jensen J, Value of retesting subjects with a positive Hemoccult in screening for colorectal cancer., Br J Surg, 1990, 77, 12, 1349-1351.

Additional files

Editorial Notes