Pediatric ANCA Associated-vasculitis (PediANCA)

May 19, 2022 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de pédiatrie 1 - CHU de Strasbourg - France
        • Sub-Investigator:
          • Sarah-Louisa MAHI, MD
        • Sub-Investigator:
          • Lucile HAUMESSER, Statistician

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

1 year to 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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.

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retrospective study of clinical and therapeutic practices at the national level.
Time Frame: Files analysed retrospectively from January 01, 2011 to December 31, 2020 will be examined]
Files analysed retrospectively from January 01, 2011 to December 31, 2020 will be examined]

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8217

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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