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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Peter Sasieni
+44 (0)20 7188 4484
peter.sasieni@kcl.ac.uk


Ms Anne Lincoln
+44(0)20 7848 8187
Annie.lincoln@kcl.ac.uk


Dr Kevin Monahan
+44 (0)20 8235 4270
k.monahan@nhs.net


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Be Part of Research - Trial Details - Examining the efficacy of faecal immunochemical testing (FIT) in patients with Lynch Syndrome
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Examining the efficacy of faecal immunochemical testing (FIT) in patients with Lynch Syndrome

Recruiting

Open to: All Genders

Age: Adult

London Birmingham London Manchester Oxford London Harrow Newcastle

Medical Conditions

Lynch Syndrome (hereditary non-polyposis colorectal cancer)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Lynch Syndrome (LS) is an inherited disorder that 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 (a test to check inside the bowels) 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Sep 2021 31 Aug 2027

Publications

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)

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.


Individuals (men and women) aged 25 – 75 years, who have a diagnosis of Lynch Syndrome.

You can take part if:



You may not be able to take part if:


1. Individuals who have not had genetic testing and therefore are not known to have Lynch Syndrome2. Individuals who have previously undergone a subtotal or total colectomy3. Individuals unable to provide informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden Hospital
    Fulham Road Chelsea
    London
    SW3 6JJ
  • Birmingham Women's and Children's NHS Foundation Trust
    Steelhouse Lane
    Birmingham
    B4 6NH
  • St George’s Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Central Manchester University Hospitals NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • John Radcliffe Hopsital
    Headley Way
    Oxford
    OX3 9DU
  • Guy’s Hospital
    Guy’s & St Thomas’ NHS Foundation Trust Great Maze Pond
    London
    SE1 9RT
  • St Mark’s Hospital
    Watford Road
    Harrow
    HA1 3UJ
  • Newcastle Hospital
    Newcastle Upon Tyne Hospital Trust High Heaton
    Newcastle
    NE7 7DN

By participating in this study there is a chance that your FIT results may provide your clinician with additional information which may assist them with your clinical care. You will also be contributing to research that will help improve surveillance for people with Lynch Syndrome in the future. There are no immediate risks in taking part in this research study, and it is unlikely that you will come to any harm while collecting a stool sample as part of the FIT kit sampling. FIT testing is used routinely as part of the National Bowel Cancer Screening Programme and has been deemed safe and effective in this setting. You may, however, be referred for an additional colonoscopy(s). Although this procedure is not considered as part of this research study, there are some risks associated with colonoscopies. Please enquire about any of these risks directly with your consultant.

Ms Anne Lincoln
+44(0)20 7848 8187
Annie.lincoln@kcl.ac.uk


Prof Peter Sasieni
+44 (0)20 7188 4484
peter.sasieni@kcl.ac.uk


Dr Kevin Monahan
+44 (0)20 8235 4270
k.monahan@nhs.net



The study is sponsored by London North West Healthcare NHS Trust and funded by MAST GROUP LIMITED; 40TUDE CURING COLON CANCER.



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Read full details for Trial ID: ISRCTN15740250

Or CPMS 48716

Last updated 06 September 2023

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