JSSc: Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06019234
Collaborator
(none)
30
1
19.1
1.6

Study Details

Study Description

Brief Summary

Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics.

The incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic level.

The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution of connectivity does not seem quite identical to the evolution of adult scleroderma, adaptation of treatments seems judicious. However, data on the evolution under therapy in children are still poor.

Complications related to the pathology, iatrogeny and diagnostic delay are the first causes of mortality from this pathology and deserve to be studied and if possible avoided.

The main hypothesis of the research being to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
    Actual Study Start Date :
    Mar 3, 2023
    Anticipated Primary Completion Date :
    Oct 3, 2024
    Anticipated Study Completion Date :
    Oct 3, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Description of the various treatments for juvenile systemic sclerosis in France [Files analysed retrospectively from January 01, 2012 to June 30, 2022 will be examined]

      The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Minor subject (<18 years old)

    • Diagnosis of systemic sclerosis between 01/01/2012 and 30/06/2022.

    • Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

    Exclusion criteria:
    • Subject (or his parents) having expressed his (their) opposition to participating in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Study Director: Ariane ZALOSZYC, MD, University Hospitals of Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06019234
    Other Study ID Numbers:
    • 9028
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 31, 2023