Skip to content

Will using a low-threshold faecal immunochemical test compared to the higher-threshold test used in the Bowel Cancer Screening Programme reduce the number of bowel cancer cases?

Double-blind, population-based, randomized controlled trial of a low-threshold faecal immunochemical test versus the usual care test in reducing colorectal cancer incidence within the Bowel Cancer Screening Programme

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74752525
Enrollment
190566
Registered
2020-10-09
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel cancer Cancer

Interventions

Assignment to either the intervention or control group will occur at the invitation to screening. The BCSS programming will be modified so that one in every 40 invitations within the eligible age rang
the referral process will be identical for

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026