Pilot Study of a National Screening Programme for Bowel Cancer in Norway
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|ClinicalTrials.gov Identifier: NCT01538550|
Recruitment Status : Recruiting
First Posted : February 24, 2012
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Adenomas||Procedure: Flexible sigmoidoscopy Procedure: iFOBT||Not Applicable|
There are several candidate screening modalities - fecal occult blood (FOBT), flexible sigmoidoscopy, colonoscopy, CT and MRI colonography and a range of molecular markers. Of these, only FOBT and FS have been subjected to long-term follow-up in randomised trials (RCTs). These two modalities will be tested in a head-to-head comparison by 1:1 randomisation. Previous studies have suggested that the attendance for FS may be lower than for FOBT. However, participation has been shown to decline with repetitive rounds required for FOBT, while infrequent or once-only screening may suffice for FS. A better test performance for FS makes it uncertain which method may be most beneficial in a public health perspective. This is the first time a national screening programme is designed as a platform for comparative effectiveness studies.
The pilot study will be carried out in two hospital catchment areas in South-East Norway - each with a target population of 70,000 men and women at 50-74 years of age - altogether 140,000 individuals to be randomised 1:1 between screening with an immunochemical test for faecal occult blood (iFOBT) biennially or FS once only. The primary endpoint is colorectal mortality reduction after 10 years. Attendance for FS is expected to be 50% and 60% for iFOBT. Expected CRC mortality reduction is 30% (286 CRC deaths) in the FS arm and 15% (143 CRC deaths) in the iFOBT arm (intention-to-treat). In a 1:1 randomisation with 80% statistical power and a significance level of 5% it will require 65,000 individuals in each arm to disclose a statistically significant difference between FS and iFOBT screening in an intention-to-treat model. We expect 5% in the iFOBTs group to test positive and require colonoscopy work-up. A positive FS is defined as 'any advanced neoplasia' (CRC, adenoma >10mm, adenoma with high-grade dysplasia or villous components). A finding of advanced neoplasia is expected in 5% of FS requiring full colonoscopy.
Study entry-date: First round screening of the iFOBT arm (70,000 invitees) has to be finished in years 1 and 2 of the trial while the flexible sigmoidoscopy arm (70,000 invitees) requires years 1-6 to be completed. Randomization of altogether 140,000 invitees was performed in year 1 of the trial - thus rendering the flexible sigmoidoscopy arm prone to more relevant time-dependent events between randomization and time of screening actually being offered. Therefore, primary entry-date was defined as day of real (for those attending) or suggested appointment (for non-attenders) in the screening arm as all letters of invitation stated a suggested day for appointment chosen by randomization. Primary entry date in the iFOBT arm was similarly defined as date of iFOBT sampling for those attending and date of mailing iFOBT-kits plus one week for non-compliant invitees. Randomization date was chosen as a secondary study entry date to allow comparative analysis of effects of choosing the two entry date definitions.Sub-studies on lifestyle, psychological reactions comparing participants and control groups not invited to screening from neighbouring municipalities are performed. A randomized sub-study comparing various premedication in work-up colonoscopies is also performed.
- Changes in modifiable lifestyle factors such as not smoking, normal weight, high level of physical activity may reduce the risk of CRC. Correlation between these factors and endoscopic findings will be assessed. Limited intervention will be tested to improve life style.
- The effect of screening on Psychological factors and the willingness to repeat screening will be assessed
- Creation of a validated Sigmoidoscopy Bowel Preparation scale with subsequent testing of various bowel preparation modalities will be performed.
- RCT with various strategies og analgesia during colonoscopy will be tested to improve patient experience.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Colorectal Cancer Screening in Norway: Pilot Study of a National Screening Programme With Randomised Comparison of Different Screening Strategies to Provide the Best Possible Service to the Population|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2030|
Experimental: Flexible sigmoidoscopy
70,000 men and women at age 50-74 years are randomised from the population registry to be invited to have a screening examination using flexible sigmoidoscopy once-only
Procedure: Flexible sigmoidoscopy
Flexible sigmoidoscopy screening is offered once only
Other Name: FlexSig= flexible sigmoidoscopy
70,000 men and women at age 50-74 years randomised from the population registry to be invited to have a screening examination biennially using an immunochemical test for fecal occult blood testing (iFOBT).
Biennial screening with iFOBT
Other Name: iFOBT = immunochemical test for fecal occult blood
- colorectal cancer mortality [ Time Frame: 10 years ]colorectal cancer mortality after 10 years of follow-up, possibly extending to 15 years of follow-up
- Colorectal cancer incidence [ Time Frame: 10 years ]Colorectal cancer incidence after 10 years of follow-up, possibly extending to 15 years of follow-up
- Complications and quality assurance [ Time Frame: 4 years ]Both screening arms will be subject to continuous registration of complications and quality assurance measures of screening itself and work-up of screening positives
- Psychological effects of screening [ Time Frame: 5 years ]The level and duration of psychological reactions to screening (anxiety, quality of life) and influence on lifestyle (smoking, physical exercise, dietary habits) will be assessed during the first 4-5 active screening years of the study
- Bowel preparation in Sigmoidoscopy [ Time Frame: 1 year start Fall 2017 ]Improved strategy for bowel preparation
- Pain reduction during Colonoscopy [ Time Frame: 18 months from Fall 2017 ]Test various strategies for analgesia during colonoscopy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538550
|Contact: Anita Jørgensen, RNfirstname.lastname@example.org|
|Contact: Øyvind Holme, MD, PhD||+4747016433||Oyvind.Holme@kreftregisteret.no|
|Oslo, Norway, 1535|
|Contact: Anita Jørgensen, RN +4793089107 email@example.com|
|Contact: Thomas de Lange, MD, PhD +4799030789 firstname.lastname@example.org..no|
|Sub-Investigator: Thomas deLange, MD,PhD|
|Principal Investigator: Per Sandvei, MD|
|Bærum County Hospital||Enrolling by invitation|
|Rud, Norway, 1309|
|Study Director:||Giske Ursin, MD, PhD||Cancer Registry of Norway, Oslo, Norway|
|Study Chair:||Kjell Magne Tveit, MD, PhD||Directorate of Health, Oslo, Norway|
|Principal Investigator:||Øyvind Holme, M.D., Ph.D.||Cancer Registry of Norway|