Pediatric ANCA Associated-vasculitis

ANCA-Associated Vasculitis Clinical Trial

— PediANCA  

Official title:

Pediatric ANCA Associated-vasculitis : Latest Clinical Review and Therapeutic Outcomes. A Retrospective Epidemiological Study on a French Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383573
• Other study ID #: 8217
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Strasbourg, France
• Contact: Ariane ZALOSZYC, MD
• Phone: 33 3 88 12 77 49
• Email: ariane.zaloszyc[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• ANCA-Associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Locations

Country	Name	City	State
France	Service de Pédiatrie 1 - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]