Bowel cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Men and women aged 60-66 years at recruitment who are eligible for FIT screening through the English BCSP
Exclusion criteria
Exclusion criteria: 1. Any individual who has opted-out of their data being used for research purposes. These individuals would be included in our initial invited population; however, we would not receive any of their data as NHS Digital removes all personal confidential information on national data opt-outs before datasets are shared 2. Individuals who were allocated to the intervention arm of the BCSP FIT pilot study 3. Individuals who are eligible to be screened but have opted-out of being invited to be screened
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of new cases of CRC diagnosed in participants who underwent at least one round of FIT screening, measured using screening outcomes during 10 years of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of CRC deaths in participants who underwent at least one round of FIT screening, measured using screening outcomes during 15 years of follow-up 2. The number of participants who a) returned a valid FIT kit, b) tested FIT positive and c) attended a diagnostic endoscopy at five biennial screening rounds over a 10-year period 3. Faecal Hb concentration measured using FIT kit at five biennial screening rounds over a 10-year period 4. The number of lesions (polyps, all adenomas, AAs, CRC) detected and their diagnostic data including number, location, size, dysplasia, histology, and stage, measured using screening outcomes at five biennial screening rounds over a 10-year period 5. The cumulative number of endoscopies carried out, including follow-up surveillance, measured using screening outcomes at five biennial screening rounds over a 10-year period 6. The predictive power of faecal Hb concentrations measured using FIT kit at earlier rounds on faecal Hb concentrations and colonoscopy outcomes at five biennial screening rounds over a 10-year period 7. The number of adverse events reported by the BCSP at five biennial screening rounds over a 10-year period 8. Costs and cost-effectiveness of low- versus higher-threshold FIT, measured using surveillance cost, Quality-Adjusted Life Years (QALYs) and cost per QALY at 15 years of follow-up | — |
Countries
England, United Kingdom