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Lynch Syndrome X-Talk of Enteral Mucosa With Immune System

Study acronym: LYNX-EYE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Study description expanded, about 5 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Lynch syndrome (OMIM #120435) is the most common dominantly inherited colorectal cancer syndrome with an estimated prevalence of 1:270 individuals. It increases the lifetime risk of colorectal and endometrial cancer primarily, but it is associated with a high risk of other cancers (pancreas, stomach, ovarian, central nervous system, skin, among others). It is caused by a germline mutation in one of four DNA mismatch repair genes or a terminal deletion of the MSH2-adjacent gene EpCAM. Despite adherence to cancer surveillance programs, many patients still develop colorectal cancer and endometrial cancer. The Prospective Lynch Syndrome Database (PLSD) suggests that more frequent surveillance intervals do not significantly improve cancer risk reduction. The PLSD also revealed that the incidence of colorectal cancer in MLH1 and MSH2 carriers was even higher than previously expected, reaching as high as 41-36% among MLH1 carriers, regardless of ethnic background. The development of colorectal cancer despite surveillance is an unresolved question. Therefore, there is an unmet need for effective cancer prevention strategies.
Trial Details
NCT Number NCT06708429
Lead Sponsor San Raffaele University
Conditions
(from sponsor)		 Lynch Syndrome, Lynch Syndrome I, Lynch Syndrome II, Lynch Syndrome I (Site-specific Colonic Cancer), HNPCC, HNPCC Gene Mutation, Hereditary Cancer Syndrome, Hereditary Cancer +14 more
Related terms Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms, Lynch syndrome I (site-specific colonic cancer), Lynch Syndrome II, Neoplastic Syndromes, Hereditary, Turcot syndrome
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov