RFIT Study
Research type
Research Study
Full title
Does repeat FIT in two week wait colorectal cancer patients provide reassurance?
IRAS ID
309269
Contact name
Sally Benton
Contact email
Sponsor organisation
Royal Surrey County Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Faecal immunochemical tests (FIT) have revolutionised asymptomatic colorectal cancer (CRC) screening and FIT have proved valuable in assessment of symptomatic patients presenting in primary (and secondary) care with lower gastrointestinal symptoms.
Through measuring faecal haemoglobin concentration (f-Hb), numerous studies have highlighted quantitative FIT as analytically highly sensitive tests that can be used to identify those symptomatic patients with a higher risk of significant colorectal disease (SCD). In addition, the finding of a f-Hb below the chosen threshold can be reassuring that a symptomatic patient is unlikely to have SCD, with high negative predictive values, thereby enabling FIT to be employed as a rule out investigation.
FIT in assessment of symptomatic patients has centred on the use of a single test and little evidence pertains to the use of replicate or repeat FIT in this clinical setting.Overwhelmingly, research has focused on FIT to help identify CRC. Although of considerable value in the assessment of SCD, some gaps in knowledge remain as to whether FIT can play a reassuring role to those with undetectable f-Hb or f-Hb below the threshold applied.
We aim to assess repeat FIT in symptomatic patients referred on the CRC two-week wait (2-WW) pathway to help address these areas. An initial FIT would be sent by the GP at the time of referral. Patient recruitment would take place at the time of 2-WW appointment. A second FIT would be returned with 7 days and a third FIT within the subsequent 5-7 days after the second and prior to definitive investigation (colonoscopy).REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0191
Date of REC Opinion
12 Jul 2022
REC opinion
Further Information Favourable Opinion