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Observational Study: LYNX EYE for Lynch Syndrome

This observational study, called LYNX EYE, is looking for 300 adults (18 years or older) with a confirmed diagnosis of Lynch Syndrome. The study aims to understand how the immune system and gut lining (enteral mucosa) interact in people with Lynch Syndrome. Researchers will use a combination of blood, mucosal (lining of the gut), and hair samples to look for specific microRNAs, antibodies (anti-frame-shift peptides), and bacteria. The main goal is to see how well these measurements can identify people at risk for developing cancer. This study is currently unclear on its recruitment status.

Study design
This is an observational study planning to enroll 300 participants. It is not specified if it is randomized, blinded, or what phase it is.
What's involved
You would undergo surveillance gastrointestinal endoscopy and/or surgery as part of your clinical care, and samples would be collected during these procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, sensitivity, will be measured through study completion, an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06708429

Lynch Syndrome X-Talk of Enteral Mucosa With Immune System

Recruiting
Not specifiedAges 18+Observational
San Raffaele University
~300 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:LYNX EYE (Lynch syndrome X-Talk of Enteral mucosa with Immune System)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over Through study completion, an average of 1 year

Conditions

Lynch Syndrome
Lynch Syndrome I
Lynch Syndrome II
Lynch Syndrome I (Site-specific Colonic Cancer)
HNPCC
HNPCC Gene Mutation
Hereditary Cancer Syndrome
Hereditary Cancer
MLH1 Gene Mutation
MLH1 Gene Deletion+Duplication
MLH1 Loss of Expression
MLH1 Gene Inactivation
MSH2 Gene Mutation
MSH2 Gene Deletion+Duplication
MSH2 Loss of Expression
MSH2 Gene Inactivation
MSH6 Gene Mutation
MSH6 Loss of Expression
MSH6 Gene Inactivation
PMS2 Gene Mutation
PMS2 Gene Inactivation
PMS2 Loss of Expression

Explore related trials

Colorectal CarcinomaEndometrial CarcinomaLynch SyndromeDNA Mismatch Repair Protein Mlh1EPCAM GeneMSH2 GeneMSH6 GenePMS2 Gene

Where it's being run

5 sites across 5 states
California1
Lombardy1
MI1
PM1
Italy1

Study leadership

  • Giulia Martina Cavestro, MD, PhD · PRINCIPAL_INVESTIGATOR · IRCCS San Raffaele Scientific Institute

Who to contact

Giulia Martina Cavestro, MD, PhD
[email protected]
0226436303
Email the study team

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Eligibility criteria

Inclusion

Age ≥18 years
All sexes eligible
Established diagnosis of Lynch syndrome performed as part of clinical practice, with a germline pathogenic/likely pathogenic variant in one of the following genes: MLH1, MSH2, MSH6, PMS2, and EpCAM
Subjects with Lynch syndrome undergoing surveillance gastrointestinal endoscopy and/or surgery according to clinical practice
Fertile patients (both males and females) are eligible
Lactating women are eligible
Age ≥18 years
All sexes eligible
Patients with sporadic colorectal lesions, including colorectal cancer and colorectal adenomas
Healthy controls without colorectal cancer or adenomas undergoing lower gastrointestinal endoscopy for abdominal pain
PREMM5 \< 2.5 \[PREMM5 is an online, free-to-use, clinical prediction algorithm that estimates the cumulative probability of an individual carrying a germline mutation in the mismatch repair genes responsible for Lynch syndrome\].

Exclusion

Age \< 18 years;
Diseases that are known to predispose to colorectal cancer (personal past or recent history of inflammatory bowel disease);
Patients unable/unwilling to provide consent;
Pregnancy

What this trial measures

  • SensitivityThrough study completion, an average of 1 year

    True positive rate: the probability of a positive test result, conditioned on the individual truly being positive