RecruitingOBSERVATIONAL

Small Bowel Capsule Endoscopy in Lynch Syndrome

This study, called iCARE4Lynch, is reviewing existing medical records of people with a specific genetic change (MMR gene variant) linked to Lynch syndrome. These are people who had a small bowel capsule endoscopy (a tiny camera pill) to check for growths or early cancers in their small bowel between 2000 and 2024. The main goal is to see how accurate this test is at finding problems. Researchers also want to understand how often issues were found, what kind of issues they were, and how these findings influenced treatment. This information will help doctors understand the best way to screen people with Lynch syndrome for these types of cancers.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

400

Start

16 Jun 2025

Estimated completion

01 Dec 2026

MMR Mutation Small Bowel Adenoma Small-bowel Adenocarcinoma Lynch Syndrome Cancer

What is this study about?

This study is called iCARE4Lynch and focuses on a condition most people haven't heard of called Lynch syndrome. If you have Lynch syndrome, it means you have a higher chance of developing certain cancers, including in your small bowel. Doctors sometimes use a test called a "small bowel capsule endoscopy" to look for these changes early. It involves swallowing a tiny camera in a pill that takes pictures as it travels through your digestive system.

This study isn't asking anyone to undergo new tests. Instead, it's looking back at the medical records of people who already had this capsule endoscopy test because they have Lynch syndrome. The researchers are checking records from the past 24 years to understand how well the capsule endoscopy test worked at finding early signs of cancer or pre-cancerous growths in the small bowel. They also want to see what happened next for these patients – did they get further tests, treatment, and how did it affect their health.

The findings from this study will help healthcare professionals understand more about detecting and managing small bowel problems in people with Lynch syndrome. By looking at a large number of past cases, they hope to improve the way these patients are screened in the future, potentially leading to earlier diagnoses and better outcomes.

Key takeaways

This study is reviewing old medical records, not testing new treatments.
It focuses on people with Lynch syndrome who had a camera pill test.
The goal is to see how well the camera pill finds early bowel changes.
No new tests or appointments are needed for this study.
Your personal details will be kept private and secure.
Findings could improve future care for Lynch syndrome patients.

Who may be eligible?

To be included in this study, you must have a confirmed genetic change linked to Lynch syndrome (specifically in one of the MLH1, MSH2, MSH6, PMS2, or EPCAM genes). You also needed to have had a small bowel capsule endoscopy specifically to look for early growths or cancers in your small bowel.

Importantly, this study only uses existing medical information. You would've needed to give your permission at some point for your past healthcare data to be used for research purposes. If you previously said you didn't want your data used for research, then you wouldn't be included.

The study also won't include anyone if there's no clear documentation of their specific Lynch syndrome genetic change in their medical records.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a confirmed Lynch syndrome genetic change?
Have you had a small bowel capsule endoscopy in the past?
Was it to check for growths or cancers in your small bowel?
Have you previously agreed for your health data to be used for research?

Answer every question to see your result.

What does participation involve?

This study involves reviewing existing health records, not active participation. If your records are included, you won't need to do anything extra, attend any appointments, take any medication, or have any follow-up visits specifically for this study. The researchers are simply looking at information that's already been collected as part of your routine medical care in the past.

Potential risks and benefits

Since this study only looks at existing, anonymous medical records, there are no direct physical risks to individual patients. Your personal information will be protected, and your name won't be used. The potential benefit is that the findings could help improve how doctors screen and care for people with Lynch syndrome in the future, potentially leading to earlier detection of small bowel problems. You have the right to withdraw your consent for your data to be used for research at any time, even if you previously agreed.

Locations (1)

Center for Digestive Endoscopy, Saint-Antoine Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is Lynch syndrome?

Lynch syndrome is an inherited condition that increases your risk of developing certain cancers, especially in the bowel.

What is a small bowel capsule endoscopy?

It's a test where you swallow a tiny camera pill that takes pictures of your small bowel as it passes through, helping doctors look for problems.

Do I need to do anything if my records are part of this study?

No, you don't need to do anything. The study only uses your past, anonymised health information if you've previously consented for medical data to be used for research.

Will my name be used in the study?

No, your personal details, including your name, will not be used. Your data will be kept private and anonymous.

How will this study help people?

It will help doctors better understand how to screen for and manage small bowel issues in people with Lynch syndrome, potentially leading to earlier diagnoses and improved care.

How to find out more

Xavier DRAY, MD PhD

xavier.dray@aphp.fr +33 (0) 1 49 28 21 61 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.