All studies
RecruitingOBSERVATIONAL

EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

The EFESO study is focused on a very rare condition known as Eosinophilic Fasciitis, which affects the tissue surrounding muscles, particularly in children. This condition can cause serious joint problems in young people. Because it’s so rare, it’s often mistaken for other conditions like juvenile systemic sclerosis or localized scleroderma. This study aims to find better ways to properly diagnose Eosinophilic Fasciitis in children without needing uncomfortable procedures like skin biopsies. We also want to understand if current treatments, like steroids and methotrexate, are truly effective for children, as there isn't much information available. Ultimately, the goal is to improve care and long-term health for children with this condition.

At a glance

Status
Recruiting
Sponsor
Meyer Children's Hospital IRCCS
Enrolment target
20
Start
15 May 2025
Estimated completion
15 May 2027

What is this study about?

This study, called EFESO, is looking at a very rare health problem in children called Eosinophilic Fasciitis. This condition causes swelling and hardening of the thin layer of tissue that covers your muscles. In children, it can particularly affect the joints, making them stiff and painful, and it might not always show up with skin problems, which is different from how it often appears in adults.

Because it's so uncommon in young people, doctors sometimes mix it up with other conditions that have similar symptoms. It's really important to get the right diagnosis so that children can get the best and most appropriate treatment for *their* specific condition. Right now, the best way to diagnose it often involves a skin biopsy, which is a small operation to remove a piece of skin for testing – and that can be hard for children.

We also know that current treatments, which often involve medicines like steroids and methotrexate, haven't been properly studied in children. We don’t really know how well they work for kids in the long run or what the best way to use them is. This study hopes to fill in these gaps, helping us understand the long-term effects of the condition and its treatments on children's overall health and quality of life.

Key takeaways

  • The EFESO study focuses on a rare condition called Eosinophilic Fasciitis in children.
  • It aims to improve diagnosis and treatment for this condition in young people.
  • The study gathers information from existing medical records, not new procedures.
  • Children under 18 at diagnosis, with at least 6 months of medical follow-up, can be included.
  • Participation potentially helps future children with this condition by improving medical knowledge.
  • All personal information is kept confidential and private.

Who may be eligible?

To be part of this study, a child must have been diagnosed with Eosinophilic Fasciitis between the year 2000 and the end of 2026. They must have been under 18 years old when they were diagnosed.

Also, a child needs to have been looked after by their doctors for at least six months after their diagnosis. Before joining, a parent or legal guardian will need to give their permission (called 'informed consent') that meets local legal requirements.

Children are not able to take part if they were 18 or older at the time of their diagnosis, if their family does not wish for them to participate, or if they have been followed up for less than six months.

Quick self-check
  • Was my child diagnosed with Eosinophilic Fasciitis between 2000 and the end of 2026?
  • Was my child under 18 years old when they were diagnosed?
  • Has my child been receiving medical care for this condition for at least 6 months?
  • Am I willing to give permission for my child's medical records to be reviewed for research?
  • Is my child currently receiving medical care for Eosinophilic Fasciitis?

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

What does participation involve?

This study primarily aims to collect and review information from children's medical records who have been diagnosed with Eosinophilic Fasciitis. It is not introducing new treatments or asking you to attend extra visits. The research team will look at information from your child's past medical appointments, treatments, and how their condition has progressed over time. The study will review records dating back to their diagnosis and continues to collect data on their progress. There are no additional assessments, medications, or visits required beyond your child's usual medical care. The length of time your child's information will be followed in the study depends on when they were diagnosed and how long they have been receiving care, with a minimum of six months of follow-up required.

Potential risks and benefits

Participating in this study involves reviewing existing medical records, so there are no direct physical risks to your child from new procedures or medicines. The main benefit is that the information gathered will help doctors better understand Eosinophilic Fasciitis in children, leading to improved diagnosis and treatment in the future. There is a small risk to your child's privacy, but strict measures are in place to keep all information confidential. You are free to withdraw your child's information from the study at any time without affecting their medical care.

Locations (15)

  • University of Alabama at Birmingham
    Birmingham, United States· Recruiting
  • SUNY Upstate Pediatric Rheumatology
    Syracuse, United States· Recruiting
  • Children's Hospital Zagreb
    Zagreb, Croatia· Recruiting
  • Hamburger Zentrum für Kinder- und Jugendrheumatologie -
    Hamburg, Germany· Not yet recruiting
  • Ruth Rappaport Children's Hospital of Haifa
    Haifa, Israel· Not yet recruiting
  • Meyer Children's Hospital IRCCS
    Florence, Italy· Recruiting
  • IRCCS Giannina Gaslini,
    Genova, Italy· Recruiting
  • Università di Udine
    Udine, Italy· Not yet recruiting
  • Iuliu Hatieganu University of Medicine and Pharmacy
    Cluj-Napoca, Romania· Recruiting
  • University Children's Hospital
    Ljubljana, Slovenia· Not yet recruiting
  • Hospital Sant Joan de Déu,
    Barcelona, Spain· Not yet recruiting
  • Astrid Lindgren Children's Hospital
    Solna, Sweden· Recruiting

+3 more sites — see the official record for the full list.

Common questions

What is Eosinophilic Fasciitis?

It's a rare condition where the deep tissue covering your muscles becomes swollen and often hardened.

Why is this study important for children?

Because the condition is so rare in children, doctors need more information to correctly diagnose it and find the best treatments for young people.

Will my child need any new tests or treatments for this study?

No, this study only collects information from your child's existing medical records. No new tests or treatments are involved.

What happens to my child's personal information?

All information is kept confidential and handled with great care to protect your child's privacy.

Can I change my mind about my child being in the study?

Yes, you can decide to withdraw your child's information from the study at any time, and it won't affect their medical care.

How to find out more

Edoardo Marrani

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

Interested in taking part?

Register your interest

Share your details and the research team for "EFESO: Study on Juvenile Onset Eosinophilic Fasciitis…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.