Lynch Syndrome (hereditary non-polyposis colorectal cancer) Cancer Malignant neoplasm of the rectum, malignant neoplasm of the colon
Conditions
Interventions
A baseline mailing will be sent to eligible participants within 30 days of their next standard of care colonoscopy to include the following study materials and items:
1. A study invitation letter
2. A
Sponsors
London North West Healthcare NHS Trust
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 3. Gut microbiota measured using 16S next-generation sequencing on residual DNA from archived FIT samples at a single time point 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 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 | — |
Countries
England, United Kingdom
Outcome results
None listed