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

NCT06019234 | Unknown

• 1 other identifier: 9028
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Systemic Sclerosis

Keywords

Systemic Sclerosis; Juvenile Systemic Sclerosis; Immunosuppressive treatments

Outcome Measures

Primary Outcomes (1)

• The therapeutic response was evaluated by the EULAR DAS 28 -CRP

  at 6 months

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \- Subject (or his parents) having expressed his (their) opposition to participating in the study

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Juvenile systemic scleroderma; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Ariane ZALOSZYC, MD

  University Hospitals of Strasbourg

  STUDY DIRECTOR

Central Study Contacts

Ariane ZALOSZYC, MD

CONTACT

33 3 88 12 77 42; ariane.zaloszyc@chru-strasbourg.fr

Rouba BECHARA, MD

CONTACT

33 3 88 12 77 42; Rouba.bechara@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 31, 2023
• Study Start: March 3, 2023
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-08

Locations

FR (1)