Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Norwegian Department of Health and Social Affairs Norwegian Cancer Society |
---|---|
Information provided by: | Norwegian Department of Health and Social Affairs |
ClinicalTrials.gov Identifier: | NCT00119912 |
The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to see if the addition of screening for occult blood in stools may contribute further to this aim. Additionally, the researchers also want to see to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening area and in areas where controlled screening is not established.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Adenoma |
Procedure: Flexible sigmoidoscopy Procedure: Fecal Occult Blood Test (FOBT) screening |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Norwegian Colorectal Cancer Prevention Trial |
Enrollment: | 100000 |
Study Start Date: | January 1999 |
Estimated Study Completion Date: | January 2017 |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing.
|
Procedure: Flexible sigmoidoscopy
Procedure: Fecal Occult Blood Test (FOBT) screening
In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
|
B: No Intervention
"No screening group" randomised from population age 50-64 years
|
Although flexible sigmoidoscopy (FS) as a screening tool has a much higher test sensitivity than fecal occult blood tests (FOBT) for colorectal cancer and high-risk adenomas, randomised trials with long-term follow-up are missing. The primary aims are as follows:
Secondary aims:
Population:
21,000 men and women, aged 50-64 years, living in the city of Oslo or the county of Telemark are drawn by randomisation (approx. 1:5) from the population registry and invited to have a flexible sigmoidoscopy examination. The control group constitutes 79,000 individuals. Those invited for flexible sigmoidoscopy are further randomised (1:1) to bring or not to bring 3 successive stool samples for FOBT on attendance for FS.
Method:
This is a once-only screening concept with bowel cleansing being limited to a 240 ml Sorbitol enema given on attendance. The threshold for work-up colonoscopy is low as a positive screening test is defined as any polyp >9mm, any histologically verified adenoma irrespective of size and a positive FOBT. The screening phase is limited to the period January 1999- January 2002 and the first follow-up results will not be reported until all entries have passed the 5-year mark (i.e. in early 2007).
Ages Eligible for Study: | 50 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Institute of Population-based Cancer Research | |
Oslo, Norway, 0310 |
Study Chair: | Frøydis Langmark, M.D. | Institute of Population-based Cancer Research |
Study ID Numbers: | NORCCAP-1, Shdir 97/08614 |
Study First Received: | July 6, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00119912 |
Health Authority: | Norway: Directorate for Health and Social Affairs |
screening flexible sigmoidoscopy fecal occult blood |
cancer colon rectum |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Adenoma Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |