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

October 30, 2023 updated by: University Hospital, Strasbourg, France

Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de pédiatrie 1 - CHU de Strasbourg - France
        • Sub-Investigator:
          • Léa JACQUEL, MD
        • Principal Investigator:
          • Ariane Zaloszyc, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rouba BECHARA, MD
        • Sub-Investigator:
          • Anne Cécile RAMEAU, MD
        • Sub-Investigator:
          • Linda ROSSI, MD
        • Sub-Investigator:
          • Meizner ULRICH, MD, PhD
        • Sub-Investigator:
          • Irène LEMELLE, MD
        • Sub-Investigator:
          • Charlotte REBELLE, MD
        • Sub-Investigator:
          • Pascal PILLET, MD
        • Sub-Investigator:
          • Pauline CHOQUET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Minor subject (<18 years old) having a systemic sclerosis between 01/01/2012 and 30/06/2022.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The therapeutic response was evaluated by the EULAR DAS 28 -CRP
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Estimated)

October 3, 2024

Study Completion (Estimated)

October 3, 2024

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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