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Pill cameras could spot rare gut cancers in lynch syndrome patients

NCT ID NCT05704010

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a swallowed video capsule (a pill-sized camera) can help find small bowel cancer early in people with Lynch syndrome, a genetic condition that raises cancer risk. About 100 participants will swallow a capsule every two years to take pictures of their small intestine. The goal is to measure how often pre-cancerous growths or cancers appear, which could guide future screening recommendations.

What this could mean

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

Active substance
Video capsule endoscopy (a pill-sized camera swallowed to take pictures of the small intestine)
What this could lead to
If successful, this study could show that regular video capsule endoscopy helps detect small bowel cancer early in people with Lynch syndrome, potentially improving outcomes.
What could go wrong
This is an observational registry, not a treatment trial. It will not test whether screening actually saves lives, and the capsule may miss some lesions. Results will take years.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

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

Started

Nov 2018

Expected to finish

Dec 2029

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Pathogenic germline variant in one of the MMR genes (MLH1, MSH2/Epcam, MSH6, or PMS2). Exclusion Criteria: * Patients younger than 18 years of age * Patients unwilling or unable to provide informed consent * Patients with prior small bowel surgery * Patients with a contraindication to VCE

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis Lynch syndrome Lynch syndrome 1 Lynch syndrome 2 small intestine adenocarcinoma

As listed by the trial registrant

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

Lynch syndrome Lynch syndrome I Lynch syndrome ii MLH1 gene mutation MSH2 gene mutation MSH6 gene mutation PMS2 gene mutation Small bowel adenocarcinoma

How to take part

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

  1. The places running it

    1 site. 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

  • San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit

    RECRUITING

    Milan, Lombardy, 20132, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.