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TerminatedNCT03800056APECED2Updated May 22, 2026

Characterization of the Fungal Origins in the Autoimmune Polyendocrinopathy of Type 1 Compared With the Autoimmune Polyendocrinopathies of Type 2

An observational study in Polyendocrinopathies, Autoimmune, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Observational

Why this study was terminated
sponsor decision, COVID
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
Up to 85 Years
Sex
All
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Study summary

Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is an autosomal recessive disease caused by mutations in the autoimmune regulator (AIRE) gene, characterized by the clinical triad of chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, and adrenal insufficiency. CMC can be complicated by systemic candidiasis or oral squamous cell carcinomas (SCCs) and may lead to death. The role of chronic Candida infection in the etiopathogenesis of oral SCC is unclear. Long term use of fluconazole lead to emergence of C. albicans strains with azoles decreased susceptibility. CMC is associated with an impaired Th17 cell response, however, it remains unclear whether decreased serum IL-17 and IL-22 levels are related to a defect in cytokine production or to neutralizing autoantibodies resulting from mutations in the AIRE gene

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Conditions studied

  • Polyendocrinopathies, Autoimmune

Keywords

  • APECED syndrome
  • autoimmune polyendocrinopathy
  • chronic mucocutaneous candidiasis
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In context

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be included during their routine follow-up for adrenal insufficiency or hypoparathyroidism in the endocrinology department of the University Hospital of Lille, in adult or pediatric endocrinology.

Inclusion criteria

  1. For both of groups, inclusion criteria are :

    • children aged 0 to 17 years old with the consent of both parents, and men and women between the ages of 18 and 85.
    • a reasonable delay of 2 weeks after the resolution of an intercurrent infectious episode is to be observed.
    • assent of the patient after information adapted to his age and his degree of understanding.
    • informed, express and written consent of the patient or of each of the holders of parental authority.
  2. Inclusion criteria specific to group 1: Patients with a APS type 1 whose molecular diagnosis (mutation of the AIRE gene) has been established in the diagnosis of the disease, regardless of their mycological status (history of mycosis) or the presence of antifungal treatment.
  3. Inclusion criteria specific to group 2 : Patients with APS type 2: - with adrenal insufficiency for 50% of them. - a delay of two weeks after stopping antifungal or antibiotic treatment in patients is to be respected.

Exclusion criteria

Exclusion Criteria:

  • impossibility to receive informed information for adults, or impossibility to receive enlightened information for the holders of parental authority if minor subject
  • inability to participate in the entire study, refusal to sign the consent.
  • people in an emergency situation.
  • persons deprived of their liberty.
  • pregnant or lactating woman (pregnant women will be offered to participate in the study after delivery).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1 APS 1

    Patients with a APS type 1 whose molecular diagnosis (mutation of the AIRE gene) has been established in the diagnosis of the disease, regardless of their mycological status (history of mycosis) or the presence of antifungal treatment.

  • Group 2 APS2

    Patients with APS type 2: - with adrenal insufficiency for 50% of them. - a delay of two weeks after stopping antifungal or antibiotic treatment in patients is to be respected.

06

What researchers measure

Primary outcomes

  1. the frequency of appearance of Candida yeast strains

    the frequency of appearance of Candida yeast strains found in mycological samples from both urinary and oral patients.

    Time frame: Baseline: one session

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Study locations

1 site
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03800056
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Jan 10, 2019
Start date
Apr 23, 2021
Primary completion
Aug 23, 2022
Completion
Aug 23, 2022
Last update
May 22, 2026

Study contacts

Marie-Christine VANTYGHEM, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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