Clinical trial · Interventional
Pilot Study of a National Screening Programme for Bowel Cancer in Norway
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenomas | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexible sigmoidoscopy | Procedure | — | UNRESOLVED |
| iFOBT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flexible sigmoidoscopy
- description
- 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
- interventionNames
- Procedure: Flexible sigmoidoscopy
- type
- EXPERIMENTAL
- label
- iFOBT
- description
- 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).
- interventionNames
- Procedure: iFOBT
Primary outcomes (1)
- measure
- colorectal cancer mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (14)
- DERIVEDSchult AL, Hoff G, Randel KR, Huppertz-Hauss G, Dalen E, Matapour S, de Lange T, Botteri E. Endoscopist as a key determinant of patient pain: a sigmoidoscopy screening model for unbiased assessment. Scand J Gastroenterol. 2026 Jun;61(6):589-597. doi: 10.1080/00365521.2026.2646941. Epub 2026 Apr 14. PMID 41981718
- DERIVEDRognstad OB, Botteri E, Hoff G, Bretthauer M, Nguyen HD, Schult AL, Holme O, Randel KR. Use of claims data to identify adverse events after colonoscopy in a randomised colorectal cancer screening trial in Norway: a cross-sectional study. BMJ Open. 2026 Jan 8;16(1):e109883. doi: 10.1136/bmjopen-2025-109883. PMID 41506765
- DERIVEDRognstad OB, Botteri E, Hoff G, Bretthauer M, Gulichsen E, Frigstad SO, Holme O, Randel KR. Adverse events after colonoscopy in a randomised colorectal cancer screening trial. BMJ Open Gastroenterol. 2024 Oct 7;11(1):e001471. doi: 10.1136/bmjgast-2024-001471. PMID 39375173
- DERIVEDRandel KR, Botteri E, de Lange T, Schult AL, Eskeland SL, El-Safadi B, Norvard ER, Bolstad N, Bretthauer M, Hoff G, Holme O. Performance of Faecal Immunochemical Testing for Colorectal Cancer Screening at Varying Positivity Thresholds. Aliment Pharmacol Ther. 2025 Jan;61(1):122-131. doi: 10.1111/apt.18314. Epub 2024 Oct 7. PMID 39373173
- DERIVEDBucher-Johannessen C, Senthakumaran T, Avershina E, Birkeland E, Hoff G, Bemanian V, Tunsjo H, Rounge TB. Species-level verification of Phascolarctobacterium association with colorectal cancer. mSystems. 2024 Oct 22;9(10):e0073424. doi: 10.1128/msystems.00734-24. Epub 2024 Sep 17. PMID 39287376
- DERIVEDRandel KR, Schult AL, Botteri E, Nawaz M, Nguyen DH, Holme O, Bretthauer M, Hoff G, de Lange T. Impact of inadequate bowel cleansing in sigmoidoscopy screening. Scand J Gastroenterol. 2024 Aug;59(8):1002-1009. doi: 10.1080/00365521.2024.2364213. Epub 2024 Jun 8. PMID 38850200