Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome

Study acronym: PREDI-ENDO
StatusNot Yet Recruiting
PhaseNot specified
Started

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Record History

  1. Minor Study First Submitted
Lynch syndrome is the most common inherited condition that raises a person's risk of getting certain cancers. It happens because of changes in genes that normally fix damaged DNA. People with Lynch syndrome have a higher chance over their lifetime of cancers like bowel, womb (endometrial), ovarian, and others. For people with a uterus, cancer of the womb lining (endometrial cancer) is often the first cancer to appear, affecting over 40% of some groups. Even though the risk is high, the current ways of checking for endometrial cancer aren't ideal. They often involve uncomfortable and invasive tests, like taking tissue samples (biopsies) or internal scans. These can be expensive and don't always catch cancer early, so many people don't keep up with regular checks. New methods are being developed that look for tiny amounts of cancer DNA in easy, non-invasive samples, like urine or self-collected vaginal swabs. These approaches could make testing easier, more comfortable, and possibly just as accurate. The PREDI-ENDO study will compare these simple tests (urine and self-collected swabs) with the standard, more invasive tests. It will include people with Lynch syndrome, those who may have symptoms, and those who would rather avoid invasive procedures. Researchers will also compare different types of samples to see which works best. About 400 women across around 20 sites in the UK will be asked to take part. They'll do these new tests alongside their usual hospital tests to see if screening can be made easier and better. The goal is to develop safer, simpler, and more reliable ways to find cancer early, and possibly replace the current invasive tests in the future.
Trial Details
NCT Number NCT07877779
Lead Sponsor University of Edinburgh
Conditions
(from sponsor)
Lynch Syndrome
Related terms Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
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