RecruitingNCT06708429

Lynch Syndrome X-Talk of Enteral Mucosa With Immune System

Impact of Immune-surveillance on the Development of Colorectal Cancer in Patients With Lynch Syndrome


Sponsor

San Raffaele University

Enrollment

300 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how the gut lining and the immune system interact in people with Lynch syndrome — a hereditary condition that greatly increases the risk of colon cancer and other cancers — compared to people without Lynch syndrome, with the goal of finding ways to prevent cancer in these individuals. **You may be eligible if...** - You are 18 or older - You have a confirmed genetic diagnosis of Lynch syndrome (mutations in MLH1, MSH2, MSH6, PMS2, or EpCAM genes) - You are scheduled for a routine bowel scope or surgery as part of your Lynch syndrome monitoring - OR you are a comparison participant with sporadic colorectal lesions or a healthy person having a routine colonoscopy **You may NOT be eligible if...** - You do not have Lynch syndrome (for the Lynch syndrome group) - You have conditions that make endoscopy or surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTLYNX EYE (Lynch syndrome X-Talk of Enteral mucosa with Immune System)

A combination of blood-based, mucosal-based, and hair-based analyses that evaluate the presence and the expression of: * a set of microRNAs (blood) * antibodies anti-frame shift peptides (blood) * mucosal-resident bacteria (healthy mucosa and cancer) * environmental exposure to potential carcinogens (hair matrix)


Locations(5)

Beckman Research Institute at City of Hope

Monrovia, California, United States

Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital

Milan, Lombardy, Italy

Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori

Milan, MI, Italy

Dipartimento di controllo qualità e rischio chimico biologico, AOOR Villa Sofia Cervello

Palermo, PM, Italy

Chirurgia Generale, Azienda Ospedaliero Universitaria di Cagliari

Cagliari, Italy

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NCT06708429


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