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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Thomas de Lange, Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT01538550
First received: February 13, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Colorectal Adenomas
Procedure: Flexible sigmoidoscopy
Procedure: iFOBT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • colorectal cancer mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    colorectal cancer mortality after 10 years of follow-up, possibly extending to 15 years of follow-up


Secondary Outcome Measures:
  • Colorectal cancer incidence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 140000
Study Start Date: March 2012
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: iFOBT
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).
Procedure: iFOBT
Biennial screening with iFOBT
Other Name: iFOBT = immunochemical test for fecal occult blood

Detailed Description:

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 1-4 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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women
  • age 50-74 years
  • living in defined geographic areas in South-East Norway (catchment areas for two hospitals)

Exclusion Criteria:

  • previous colorectal cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538550

Locations
Norway
Cancer Registry of Norway
Oslo, Norway, 0304
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Investigators
Study Director: Giske Ursin, Md, PhD Cancer Registry of Norway, Oslo, Norway
Study Chair: Hans Petter Aarseth, MD Directorate of Health, Oslo, Norway
Principal Investigator: Thomas de Lange, M.D., Ph.D. Cancer Registry of Norway
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas de Lange, Head of section for colorectal cancer screening, Cancer Registry of Norway, Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier: NCT01538550     History of Changes
Other Study ID Numbers: CRCpilotNorway
Study First Received: February 13, 2012
Last Updated: April 1, 2014
Health Authority: Norway: Directorate of Health

Keywords provided by Norwegian Department of Health and Social Affairs:
cancer
colon
rectum
adenoma
screening
iFOBT
flexible sigmoidoscopy
randomized trial

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 23, 2014