ClinicalTrials.gov record NCT07348263
EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
International Multicentre Cohort Study on Clinical Manifestations and Response to Therapy in Juvenile Onset Eosinophilic Fasciitis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective, multicentre observational cohort study of children diagnosed with eosinophilic fasciitis before age 18. It collects past clinical and laboratory information, how patients were treated, and follow-up outcomes. The study includes JEF cases diagnosed by deep fascial biopsy or by typical MRI findings, and a 1:1 comparison group of patients with localized or systemic scleroderma who had a deep fascial biopsy.
What it is studying. The study aims to describe how juvenile-onset eosinophilic fasciitis presents and progresses, what treatments were used, and how patients responded, by comparing biopsy-confirmed and MRI-diagnosed cases and a 1:1 comparison group of scleroderma patients.
What the researchers hope to learn. Describe clinical and laboratory features at presentation and during follow-up; document treatments given and responses in children; clarify long-term outcomes such as functional limitations, quality of life, and treatment-related complications.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Eosinophilic fasciitis is a connective tissue disorder characterized by inflammation of the muscle fasciae, which is very rare in children. In juvenile-onset eosinophilic fasciitis (JEF), there may be severe joint involvement and skin manifestations may be less prevalent than in adults. It represents an important differential diagnosis of both juvenile-onset systemic sclerosis and localized scleroderma, and the correct classification of these patients is necessary to define a targeted diagnostic-therapeutic pathway. The diagnostic criteria proposed for eosinophilic fasciitis in the adult population do not necessarily require confirmation by skin biopsy, currently the "gold standard," which is an invasive procedure for pediatric patients; however, these criteria have never been directly applied to the pediatric population. From a therapeutic point of view, the combination of glucocorticoids and methotrexate is recommended for both adults and pediatric patients, but the data supporting this treatment in children are very limited, and there are no studies comparing the therapeutic approaches currently in use in pediatrics. Finally, there are no studies in the literature documenting the long-term prognosis of these patients in terms of functional limitations, quality of life, or complications related to the disease or treatments.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Inclusion criterai:
- All patients diagnosed from 2000 to 31/12/2026
- minimum follow-up 6 months
- Age <18 years at diagnosis;
- All patients whose informed consent is collected in accordance with current local legislation will also be considered enrollable.
Exclusion criteria
- Age ≥18 years at diagnosis;
- Unwilling to participate into the study;
- A follow-up period < 6 months.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective observational study: with consent, researchers will review your past medical records, including clinical notes, laboratory results, MRI reports, and deep fascial biopsy reports if available. The team will collect information from presentation through follow-up (minimum 6 months) to describe symptoms, skin and joint findings, and laboratory features. No study-assigned treatments are given as part of this study. The record does not state any new or invasive procedures that participants must undergo.
How the study is structured. A retrospective observational cohort using past medical records from multiple centres. It groups JEF patients into biopsy-confirmed and MRI-diagnosed populations and enrolls a 1:1 comparison group of scleroderma patients with deep fascial biopsy; data on presentation, labs, imaging, treatments, and follow-up are collected and analyzed.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Croatia, Germany, Israel, Italy, Romania, Slovenia, Spain, Sweden, Turkey, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on eosinophilic fasciitis
Important dates
- Study start
- May 15, 2025
- Primary completion
- May 15, 2026 (estimated)
- Study completion
- May 15, 2027 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Mar 11, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Principal investigator
- Gabriele Simonini, MD
Meyer Children's Hospital IRCCS
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Edoardo Marrani 📞 +390555662913 ✉ edoardo.marrani@meyer.it
Participating sites (15)
- University of Alabama at BirminghamRecruiting
Birmingham, Alabama, 35294 · United States
- SUNY Upstate Pediatric RheumatologyRecruiting
Syracuse, New York, 13210 · United States
- Children's Hospital ZagrebRecruiting
Zagreb, 10000 · Croatia
- Hamburger Zentrum für Kinder- und Jugendrheumatologie -Not Yet Recruiting
Hamburg · Germany
- Ivan Foldvari · foeldvari@t-online.de
- Ruth Rappaport Children's Hospital of HaifaNot Yet Recruiting
Haifa · Israel
- Meyer Children's Hospital IRCCSRecruiting
Florence, FI, 50139 · Italy
- Edoardo Marrani · +390555662913 · edoardo.marrani@meyer.it
- IRCCS Giannina Gaslini,Recruiting
Genova · Italy
- Riccardo Papa · riccardo.papa@gaslini.it
- Università di UdineNot Yet Recruiting
Udine · Italy
- Giorgia Martini · giorgia.martini@uniud.it
- Iuliu Hatieganu University of Medicine and PharmacyRecruiting
Cluj-Napoca · Romania
- University Children's HospitalNot Yet Recruiting
Ljubljana · Slovenia
- Natasa Toplak · natasa.toplak@kclj.si
Terms used on this page · explanations by MedicalUpdates.ai
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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