Clinical Trial: Pilot Study of a National Screening Programme for Bowel Cancer in Norway

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief Summary: The Norwegian government has funded a pilot study of a national colorectal cancer screening programme. This implies initiation of a screening pilot in the catchment area for two hospitals in Norway. The target population is average risk men and women at age 50-74 years. The programme is designed as a comparative effectiveness programme evaluating acceptance and test performance for two screening methods - fecal occult blood testing (FOBT) and flexible sigmoidoscopy (FS). This protocol describes the main methodological issues, necessary resources and the expected effects.

Detailed Summary:

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 adv
Sponsor: Norwegian Department of Health and Social Affairs

Current Primary Outcome: colorectal cancer mortality [ Time Frame: 10 years ]

colorectal cancer mortality after 10 years of follow-up, possibly extending to 15 years of follow-up


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Norwegian Department of Health and Social Affairs

Dates:
Date Received: February 13, 2012
Date Started: March 2012
Date Completion: December 2030
Last Updated: April 13, 2015
Last Verified: April 2015