Pediatric ANCA Associated-vasculitis

NCT05383573 | Unknown

• 1 other identifier: 8217
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence in pediatrics is very low (about 0.5 per million according to a French study) and therefore the data on the pathology very poor, especially on the therapeutic level. Without appropriate treatment, the mortality rate of the pathology is very high. Existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments. Complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. The purpose of the study is to achieve a national comparison of clinical and therapeutic practices.

Conditions

ANCA-Associated Vasculitis

Keywords

ANCA-Associated Vasculitis; Pediatric ANCA; Vasculitis

Outcome Measures

Primary Outcomes (1)

• Retrospective study of clinical and therapeutic practices at the national level.

  Files analysed retrospectively from January 01, 2011 to December 31, 2020 will be examined]

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Minor subject (\<18 years old) with diagnosis of ANCA vasculitis according to the international criteria for defining the pathology, GPA or MPA form between 2011 and 2020.

You may qualify if:

• Minor subject (\<18 years old)
• Diagnosis of ANCA vasculitis according to the international criteria for defining the pathology, GPA or MPA form between 2011 and 2020.
• 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
• Patients with vasculitis has ANCA in the form of EGPA
• Associated pathologies that cannot be related to the diagnosis of ANCA vasculitis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

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

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ariane ZALOSZYC, MD

CONTACT

33 3 88 12 77 49; ariane.zaloszyc@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@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: May 12, 2022
• First Posted: May 20, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

FR (1)