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?
| ISRCTN | ISRCTN74752525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74752525 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 279464 |
| Protocol serial number | 20SM5904, IRAS 279464 |
| Sponsor | Imperial College London |
| Funder | Cancer Research UK |
- Submission date
- 02/10/2020
- Registration date
- 09/10/2020
- Last edited
- 13/02/2025
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The NHS Bowel Cancer Screening Programme (BCSP) offers a stool test every 2 years which checks for the presence of blood as this may indicate bowel cancer or something that may develop into cancer over time. From June 2019, the BCSP began using a new stool test called FIT, which quantifies how much blood, if any, is present. If the FIT result gives a level above a certain number or threshold, the patient is referred for a more invasive examination. This threshold can be set at any level, but in general, the lower the FIT threshold, the more sensitive the test, resulting in more bowel cancers being detected. Therefore, the optimal FIT threshold must balance the benefits of detecting potential cancers early versus the risk and costs of undergoing more invasive investigations.
The main aim of this study is to determine if using a low-threshold FIT compared to the higher-threshold FIT used in the BCSP will reduce the number of bowel cancer cases. This is important because if the study shows that low-threshold FIT reduces the number of bowel cancers and subsequent deaths, and is cost-effective, a strong case could be made to lower the FIT threshold used in the BCSP. This would mean that everyone taking part in screening would benefit from a more sensitive test.
Who can participate?
Men and women aged 60-66 who are eligible for FIT screening through the English BCSP
What does the study involve?
Participants will be recruited through the BCSP and randomly allocated to either a low- or the standard higher-threshold FIT used in the BCSP. Recruited participants will complete their bowel cancer screening as normal. Over a 10-year period, the researchers will examine data from up to five FITs per person to determine how much more effective low-threshold FIT is at reducing the number of bowel cancers and subsequent deaths from this disease.
What are the possible benefits and risks of participating?
For those participants allocated to a low-threshold FIT, there is the potential of detecting and treating a precancerous lesion or cancer at an earlier time due to the use of a more sensitive test. There are minimal risks for participants as they are not being exposed to novel or experimental products or procedures. Participants assigned to the low-threshold FIT are more likely to be referred for an invasive examination, such as a colonoscopy, as this threshold is more sensitive than the higher, usual-care, threshold. Colonoscopies are a safe examination performed routinely within the BCSP for a positive stool test by a registered screening specialist practitioner and the risks associated with colonoscopy are extremely low. Additionally, the low threshold for the FIT has been applied as standard in screening programmes in other countries. The Data Safety Monitoring Committee (DSMC) will regularly review and monitor reported adverse events throughout the duration of the study to assess and ensure the continued safety of participants.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
April 2020 to April 2038
Who is funding the study?
Cancer Research UK
Who is the main contact?
Prof. Amanda Cross
amanda.cross@imperial.ac.uk
Contact information
Scientific
Imperial College London
St Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
 ORCID ID |
0000-0002-0893-2377 |
|---|---|
| Phone | +44 (0)20 7594 3401 |
| amanda.cross@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind population-based nationwide randomized controlled trial with a parallel-arm design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | FIT for Screening |
| Study objectives | To determine whether screening with low threshold (20 µg/g) FIT can reduce incidence rates of colorectal cancer (CRC). |
| Ethics approval(s) | Approved 13/11/2020, London - Surrey REC (Nottingham Centre, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)2071048088, (0)2071048102, (0)2071048388; surrey.rec@hra.nhs.uk), ref: 20/LO/1188 |
| Health condition(s) or problem(s) studied | Bowel cancer |
| Intervention | 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 range will be allocated to the intervention arm in order to spread out the additional colonoscopies that will be required. As the order of invitations are not affected by subject demographics, and the protocol for the intervention and control arms is the same until after the return of the FIT, allocation to either arm will not be influenced by age, sex, screening history or index of deprivation and will effectively be random. Participants, screening centres, and endoscopists will be blinded to allocation. Five invites in each block of 40 invitations will be allocated to the trial, four to the control arm and one to the intervention arm. Only individuals who return a valid FIT kit at the first round will be enrolled in the trial. All participants will receive the same FIT device as is sent out through the BCSP. The device will be sent inside a box, which also contains the screening invitation letter and instructions for using the device. BCSP invitees are asked to collect a single faecal sample using the FIT device, record the sample collection date on the kit and post it immediately to their designated screening hub, in prepaid, addressed envelopes. For the intervention group, a FIT threshold of 20 μg/g will indicate positivity at the first and up to five subsequent rounds of FIT screening. For the control group, the FIT threshold that will be used as standard practice in the BCSP, currently 120 μg/g, will be applied. Participants with a faecal Hb concentration above their assigned threshold will be referred to an SSP for endoscopy; the referral process will be identical for each trial arm and is the standard process for the NHS BCSP. The trial will be conducted over a 10-year period, running over five biennial screening rounds. The study period of 10 years will allow the researchers to examine the effects of multiple FIT screening rounds. Trial follow-up will continue for an additional 5-year period, to permit sufficient cases to accrue to examine the effect on CRC mortality. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/04/2038 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 66 Years |
| Sex | All |
| Target sample size at registration | 190566 |
| Key inclusion criteria | Men and women aged 60-66 years at recruitment who are eligible for FIT screening through the English BCSP |
| Key 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 |
| Date of first enrolment | 01/01/2025 |
| Date of final enrolment | 01/03/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2025: The study was stopped before opening to recruitment.
04/04/2024: The following changes were made to the trial record:
1. The overall end date was changed from 01/04/2037 to 01/04/2038.
2. The recruitment start date was changed from 01/04/2024 to 01/01/2025.
3. The recruitment end date was changed from 01/06/2025 to 01/03/2026.
4. The plain English summary was updated to reflect these changes.
04/09/2023: The following changes were made:
1. The overall study end date was changed from 01/04/2036 to 01/04/2037 and the plain English summary was updated accordingly.
2. The recruitment start date was changed from 01/09/2023 to 01/04/2024.
3. The recruitment end date was changed from 01/11/2024 to 01/06/2025.
07/03/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2023 to 01/09/2023.
2. The recruitment end date was changed from 01/05/2024 to 01/11/2024.
02/09/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2022 to 01/03/2023.
2. The recruitment end date was changed from 01/03/2023 to 01/05/2024.
01/03/2022: The recruitment start date was changed from 01/03/2022 to 01/09/2022.
02/09/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2021 to 01/03/2022.
2. The recruitment end date has been changed from 01/04/2022 to 01/03/2023.
07/04/2021: The recruitment start date was changed from 01/04/2021 to 01/09/2021.
08/10/2020: Trial's existence confirmed by Cancer Research UK.
