Examining the efficacy of faecal immunochemical testing (FIT) in patients with Lynch Syndrome

Not Applicable

• Conditions: ynch Syndrome (hereditary non-polyposis colorectal cancer); Cancer; Malignant neoplasm of the rectum, malignant neoplasm of the colon

• Registration Number: ISRCTN15740250
• Lead Sponsor: ondon North West Healthcare NHS Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36344941/ (added 08/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37668669/ (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-13
• Last Update Posted: 18 September 2023
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

1. Individuals (men and women) who have a diagnosis of Lynch Syndrome (as defined by a confirmed mutation in any of the mismatch repair genes (MLH1, MSH2, MSH6, PMS2 or EPCAM),
2. Between the age of 25 - 75 years
3. Have a scheduled standard of care (SOC) routine colonoscopy appointment within the 12 months at start of study recruitment

Exclusion Criteria

1. Individuals who have not had genetic testing and therefore are not known to have Lynch Syndrome
2. Individuals who have previously undergone a subtotal or total colectomy
3. Individuals unable to provide informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation of no visible CRC at time of colonoscopy and subsequent negative pathology report for patients who had preceding negative FIT results. The absence of colorectal cancer is measured by colonoscopy for participants with preceding negative FIT results (<6 micrograms of haemoglobin / g of faeces) at Baseline and Year 2

Secondary Outcome Measures

Name	Time	Method
1. The overall acceptability of this novel intervention (FIT) by this patient population (Lynch Syndrome) will be measured through the use of a participant questionnaire which will be distributed at baseline<br>2. Confirmation of colorectal neoplasia (CN) at time of colonoscopy, and subsequent confirmation via pathology report for patients who had preceding positive FIT results over the 3-year interventional follow-up period<br>3. Gut microbiota measured using 16S next-generation sequencing on residual DNA from archived FIT samples at a single time point<br>4. Colorectal cancer (CRC) diagnoses from patient records in a subset of patients who had negative FIT results at Baseline and Years 1-3 to record for potential interval cancers through Baseline, Years 1-3, and passive follow-up years 4-6<br>5. Advanced colorectal neoplasia (ACN) at time of colonoscopy, and subsequent confirmation of malignancy on pathology report using patient records over the 5 year follow up period