FIT for Screening v1.0

• Research type

  Research Study

• Full title

  Double-blind, population-based, randomised controlled trial of low threshold faecal immunochemical test (FIT) versus usual care FIT in reducing colorectal cancer (CRC) incidence within the Bowel Cancer Screening Programme.

• IRAS ID

  279464

• Contact name

  Amanda Cross

• Sponsor organisation

  Imperial College London

• ISRCTN Number

  ISRCTN74752525

• Duration of Study in the UK

  15 years, 0 months, 1 days

• Research summary

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

  The NHS BCSP offers a stool test every two 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 of undergoing more invasive investigations.

  In this randomised controlled trial, men and women aged 60-66 years across England will be recruited via the BCSP and randomly assigned 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, we 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. This is important because if the trial 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. This trial is funded by Cancer Research UK.
  

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  20/LO/1188

• Date of REC Opinion

  13 Nov 2020

• REC opinion

  Favourable Opinion