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New study aims to unlock why lynch syndrome patients still get cancer despite surveillance

NCT ID NCT06708429

Knowledge-focused Sponsor: San Raffaele University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 300 people with Lynch syndrome, a genetic condition that raises the risk of colorectal cancer. Researchers want to understand why some patients still develop cancer even with regular check-ups. They will analyze blood, gut bacteria, and hair samples to find clues that could lead to better prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to predict and prevent colorectal cancer in people with Lynch syndrome.
What could go wrong
This is an observational study, so it won't directly test a treatment. Results may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll patients with and without Lynch syndrome, with and without colorectal cancer or colorectal adenomas.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal adenoma colorectal cancer colorectal neoplasm Colorectal Neoplasms, Hereditary Nonpolyposis endometrium neoplasm hereditary neoplastic syndrome hereditary nonpolyposis colon cancer Lynch syndrome Lynch syndrome 1 Lynch syndrome 2 mismatch repair cancer syndrome 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary cancer Hereditary cancer syndrome HNPCC HNPCC gene mutation Lynch syndrome Lynch syndrome I Lynch syndrome I (site-specific colonic cancer) Lynch syndrome ii MLH1 gene deletion+duplication MLH1 gene inactivation MLH1 gene mutation MLH1 loss of expression MSH2 gene deletion+duplication MSH2 gene inactivation MSH2 gene mutation MSH2 loss of expression MSH6 gene inactivation MSH6 gene mutation MSH6 loss of expression PMS2 gene inactivation PMS2 gene mutation PMS2 loss of expression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beckman Research Institute at City of Hope

    RECRUITING

    Monrovia, California, 91016, United States

  • Chirurgia Generale, Azienda Ospedaliero Universitaria di Cagliari

    RECRUITING

    Cagliari, Italy

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

    RECRUITING

    Milan, MI, Italy

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

    RECRUITING

    Palermo, PM, Italy

  • Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital

    RECRUITING

    Milan, Lombardy, 20132, Italy

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