FIT for Lynch Syndrome V. 1.0
Research type
Research Study
Full title
Exploring the utility and acceptability of Faecal Immunochemical Testing (FIT) as a novel intervention for the improvement of Colorectal Cancer (CRC) surveillance in individuals with Lynch Syndrome.
IRAS ID
280583
Contact name
Kevin Monahan
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
ISRCTN Number
ISRCTN15740250
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Lynch Syndrome (LS) is an inherited disorder characterised by mutations found in mismatch repair (MMR) genes. This syndrome results in an increased lifetime risk of several cancers, including colorectal cancer (CRC). It is estimated that nearly 175,000 people in the U.K. have Lynch Syndrome, though fewer than 5% (~8,750) are known.
Given the increased risk of CRC for individuals with LS, colonoscopy is recommended every two years for patients with LS within England., which may begin between the ages of 25 – 35 and last until 75 years of age. Though colonoscopy is presently considered the gold standard for the detection of colonic lesions, the requirement of having up to 25 colonoscopies throughout a LS patient’s lifetime is invasive and resource intensive.
For this research study, we are proposing the use of a non-invasive, self-sampling diagnostic device known as the faecal immunochemical testing (FIT) kit for patients with LS. FIT is a CLIA-waived diagnostic device designed to detect trace amounts of faecal haemoglobin (f-Hb) and used to guide clinical referral for lower gastrointestinal investigation, often to colonoscopy. Despite the routine use of FIT in population-based CRC screening programmes within the U.K. and abroad, the role of FIT for patients with LS is unknown.
In this study, we will offer eligible LS patients an OC-Sensor™ FIT kit via mail at baseline, and annually for 3 years thereafter. Patients will also receive additional study materials at baseline, as well as a pre-notification letter just prior to baseline. After the trial has ended, we will continue to passively observe a subset of trial participants (those with preceding negative FIT results), for the observation of interval CRC’s. The mechanism for collecting long-term follow up data at 3 years is dependent on future funding, however, and will therefore be decided at a later date.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0066
Date of REC Opinion
25 Mar 2021
REC opinion
Further Information Favourable Opinion