Understanding the immune response in Lynch syndrome patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between the immune system and the enteral mucosa in individuals with Lynch syndrome, a genetic condition that significantly increases the risk of colorectal and endometrial cancers. It aims to identify anti-frame-shift peptide antibodies as potential early biomarkers for cancer development in these patients. By employing a retro-prospective design, the study seeks to explore the biological processes that lead to interval colorectal cancers, which occur despite regular surveillance. Participants will include those with Lynch syndrome as well as healthy controls and patients with sporadic colorectal lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria (for participants with Lynch syndrome):

* 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

Inclusion Criteria (for participants without Lynch syndrome):

* 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 Criteria (for participants with or without Lynch syndrome):

* 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

Where it's running

• Beckman Research Institute at City of Hope
  Monrovia, California, United States Recruiting
• Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital
  Milan, Lombardy, Italy Recruiting
• Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori
  Milan, Mi, Italy Recruiting
• Dipartimento di controllo qualità e rischio chimico biologico, AOOR Villa Sofia Cervello
  Palermo, Pm, Italy Recruiting
• Chirurgia Generale, Azienda Ospedaliero Universitaria di Cagliari
  Cagliari, Italy Recruiting

Study contacts

• Principal investigator: Giulia Martina Cavestro, MD, PhD — IRCCS San Raffaele Scientific Institute
• Study coordinator: Giulia Martina Cavestro, MD, PhD
• Email: cavestro.giuliamartina@hsr.it
• Phone: 0226436303

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Liquid biopsy and machine learning to detect early colorectal cancer, advanced adenomas, Lynch-related cancers, and residual disease

  This project will test a blood-based liquid biopsy that uses microRNA signals and machine learning to detect colorectal cancer, advanced adenomas, Lynch-associated cancers, and molecular residual disease in people who have a colonoscopy.

  Recruiting San Raffaele University · Milan, Lombardy and 3 other locations · NCT07450612

• Using videocapsule endoscopy to detect small bowel cancer in Lynch syndrome patients

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  Recruiting Columbia University · New York, New York · NCT07876349

• Capsule camera screening of the small intestine for people with Lynch syndrome

  This project looks back at past small-bowel capsule endoscopy exams to see if they detect precancerous lesions or early cancer in people with Lynch syndrome.

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• Cutting down ultra-processed foods for people at high cancer risk

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.