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Clinical Trials/NCT03751683
NCT03751683
Completed
Not Applicable

Evaluation Genotypic, Phenotypic and Prognosis Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) Syndrome

University Hospital, Lille1 site in 1 country29 target enrollmentJuly 30, 2009
ConditionsAPECED

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
APECED
Sponsor
University Hospital, Lille
Enrollment
29
Locations
1
Primary Endpoint
allelic frequency of the mutation c.967-979del13 of the AIRE gene
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated

Registry
clinicaltrials.gov
Start Date
July 30, 2009
End Date
January 25, 2018
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients with at least 2 major criteria out of the following 3: hypoparathyroidism of autoimmune origin, adrenal insufficiency of autoimmune origin, chronic cutaneous and mucosal candidiasis.
  • patients with only 1 of the 3 major criteria, associated with at least 2 of the following minor criteria: hypergonadotropic hypogonadism of autoimmune origin, atrophic gastritis, malabsorption, autoimmune hepatitis, vitiligo, alopecia, chronic keratoconjunctivitis, hypoplasia of dental enamel.
  • patients whose molecular diagnosis has been established or who will be established during the inclusion visit with the genetic sample.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

allelic frequency of the mutation c.967-979del13 of the AIRE gene

Time Frame: Baseline: one session

Secondary Outcomes

  • the distribution of lymphocyte subpopulations on the whole cases with APECED syndrome.(Baseline: one session)
  • total number of cases recognized APECED syndrome regardless of the diagnostic criteria used.(Baseline: one session)
  • correlations between the clinical phenotype and the autoantibodies on all cases with APECED syndrome.(Baseline: one session)
  • correlations between the mutations of the AIRE gene and the HLA genotyping on all cases with APECED syndrome.(Baseline: one session)
  • proportion of patients with a molecular diagnosis of positive APECED syndrome, among patients presenting our new diagnostic criteria (a major criterion and at least 2 criteria(Baseline: one session)
  • prevalence of types of antibodies found on APECED syndrome.(Baseline: one session)

Study Sites (1)

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