Clincosm LogoSign in Get a demo

PediANCA: Pediatric ANCA Associated-vasculitis

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05383573
Collaborator
(none)
500
Enrollment
1
Location
12
Anticipated Duration (Months)
41.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Pediatric ANCA Associated-vasculitis : Latest Clinical Review and Therapeutic Outcomes. A Retrospective Epidemiological Study on a French Cohort
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    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

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    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.

    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

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05383573
    Other Study ID Numbers:
    • 8217
    First Posted:
    May 20, 2022
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    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
    ANCA-Associated Vasculitis
    Pediatric ANCA
    Vasculitis
    Additional relevant MeSH terms:
    Vasculitis
    Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

    Study Results

    No Results Posted as of May 20, 2022