Colorectal neoplasm
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligible for inclusion are participants in the national cancer screening programmes in Norway, Poland, Spain, Italy, Denmark, and Japan who undergo either primary colonoscopy screening or colonoscopy after a positive faecal immunochemical screening test.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the screening programmes are applied in the present study (e.g., individuals with previous history of colorectal cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Short-term primary endpoints 1. Adenoma detection rate (ADR) 2. Advanced adenoma detection rate (A-ADR) -Long-term primary endpoints 1. Incidence of colorectal cancers after 10-years follow-up 2. Mortality from colorectal cancers after 10-years follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of endoscopists with ADRs 25% or higher 8 2. Serrated polyp detection rate 3. Mean number of adenomas per colonoscopy 4. Learning effect of using AI during colonoscopy 5. Benefits from the use of AI according to the expertise 6. Comparison of different AI systems 7. Colonoscopy performance (e.g., cecal intubation rate, insertion and withdrawal time). 8. Rate of adverse events during and within 30 days after colonoscopy 9. Incidence of colorectal cancers in 15-year follow-up 10. Mortality from colorectal cancers in 15-year follow-up 11. All-cause mortality in 10-year and 15-year follow-up 12. Mortality due to causes other than colorectal cancer in 10-year and 15-year follow-up 13. Cost-effectiveness of using AI in a cancer screening programme for colorectal cancer. 14. Retrospective analysis of recorded videos for individuals who have cancer or relevant lesions detected after colonoscopy screening. | — |
Countries
Japan,Europe
Contacts
University of Oslo Clinical Effectiveness Research Group