RecruitingNAINTERVENTIONAL

Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease

This study is investigating Behçet disease in children and adults to gain a deeper understanding of this condition. Behçet disease is a long-term illness that causes inflammation in various body parts. It's quite rare in children, and often harder to diagnose early because the symptoms can be different and show up over time. Researchers will collect blood samples from children and adults with Behçet disease, as well as healthy children. They will look for specific markers in the blood, such as special proteins and genetic information, that might explain why some people get Behçet disease and how it affects them. By comparing these markers, the study hopes to identify different types of Behçet disease and develop better ways to tell how severe it is and if treatments are working, especially for young patients.

At a glance

Status

Recruiting

Phase

Sponsor

Meyer Children's Hospital IRCCS

Enrolment target

Start

12 Jan 2026

Estimated completion

01 Jan 2036

Behcet Disease and Vascular Involvement

What is this study about?

Behçet disease is a long-term condition that causes inflammation throughout the body, affecting areas like the skin, eyes, blood vessels, and joints. While it can affect anyone, it's quite rare in children. When children do get it, their symptoms can vary a lot, and it can be tricky for doctors to diagnose early on, as the full picture of the disease might not be clear at first.

This study aims to get a much clearer picture of what's happening inside the bodies of children and adults with Behçet disease. To do this, researchers will carefully collect and examine blood samples. They'll be looking for tiny clues – like specific proteins called cytokines, small genetic messengers called microRNAs, and changes in our DNA – that could act as 'fingerprints' for the disease. By comparing these 'fingerprints' from people with Behçet disease to those of healthy children, they hope to understand the differences and similarities.

The main goal is to use all this information to find out if there are different types of Behçet disease, particularly in children. This could lead to better ways for doctors to diagnose the condition earlier, understand how it will progress, and even help them choose the most effective treatments for each person. Ultimately, this research could pave the way for more personalized care for children with Behçet disease.

Key takeaways

This study focuses on Behçet disease in children and adults.
It aims to find new ways to understand and diagnose the disease, especially in younger patients.
Participation involves providing blood samples at regular intervals during routine clinic visits.
The study compares blood markers from people with Behçet disease to healthy children.
There are no new medicines or treatments involved; it's purely observational research.
The goal is to develop more targeted and personalised care for Behçet disease in the future.

Who may be eligible?

To join this study, people must be between 6 months and 70 years old. If you have been diagnosed with Behçet disease by a doctor, using specific guidelines, you might be able to participate. It's really important that your diagnosis of Behçet disease is clear, and that other similar conditions have been ruled out. All participants, or their parents if they are a child, must give their written permission to take part.

Healthy children can also join the study as a comparison group. These are children under 18 who are having routine blood tests at the Meyer Children's Hospital and do not have any inflammatory or autoimmune conditions. They should not have used certain medications like anti-inflammatories or steroids for a long time recently. These healthy children will be matched by age and gender to the children with Behçet disease.

However, you cannot join if you don't meet the diagnosis criteria for Behçet disease, or if there's any doubt about your diagnosis. For healthy children, you cannot join if you have any ongoing inflammatory or autoimmune conditions, or if you've recently used certain medications for more than a week.

Quick self-check

Are you between 6 months and 70 years of age?
Do you have a clear diagnosis of Behçet disease from a doctor?
If you are a child, are your parents/guardians willing to give permission?
If you are a healthy child participant, are you having routine blood tests at Meyer Children's Hospital?
Have you recently avoided using anti-inflammatory or steroid medications for longer than 7 days?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will have blood samples taken during your routine doctor's visits. These samples will be collected when you are first diagnosed, when your Behçet disease is stable and under control, and if you have a flare-up of your condition. This means that if your condition changes, you might be asked to provide an additional sample.

For healthy children, a blood sample will be taken during a routine appointment where blood tests are already planned. The researchers will then analyse these blood samples to look for specific markers. The study will follow your progress over time, and blood samples will be taken at different stages of your disease. You won't need to take any new medications for the study; it focuses on analysing routine blood samples. The total duration of participation depends on your disease course and the planned follow-up appointments.

Potential risks and benefits

Taking part in this study might benefit you by helping researchers better understand Behçet disease, which could lead to improved diagnosis and treatment for others, and potentially for you in the future. However, there's no direct guarantee that you will personally benefit from this research. The risks are very low, mainly associated with the blood collection, which might cause some mild discomfort, bruising, or rarely, a minor infection at the site where the blood is drawn. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Aou Meyer IRCSS
Florence, Italy· Recruiting
Alder Hey Children's Hospital,
Liverpool, United Kingdom· Not yet recruiting

Common questions

What is Behçet disease?

Behçet disease is a long-term condition that causes inflammation in various body parts, such as the mouth, eyes, skin, and joints. It's an autoimmune disease, meaning the body's immune system mistakenly attacks healthy tissues.

Why is this study important for children?

Behçet disease is rare in children and can be hard to diagnose early. This study aims to find specific clues in children's bodies to help doctors better understand, diagnose, and treat the condition specifically in young patients.

What will be done with my blood samples?

Researchers will look for tiny clues in your blood like special proteins (cytokines), small genetic messengers (microRNAs), and changes in your DNA. These clues are like 'fingerprints' that might help explain Behçet disease.

Do I have to take any new medicine for this study?

No, you will not have to take any new medicines as part of this study. It only involves collecting blood samples during your regular doctor's visits.

Can I stop being part of the study if I change my mind?

Yes, you are completely free to withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Gabriele Simonini

gabriele.simonini@unifi.it +390555662545 Official trial record

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