- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03800056
Characterization of the Fungal Origins in the Autoimmune Polyendocrinopathy of Type 1 Compared With the Autoimmune Polyendocrinopathies of Type 2 (APECED2)
February 15, 2022 updated by: University Hospital, Lille
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
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie-Christine VANTYGHEM, MD,PhD
- Phone Number: +33 320 44 45 17
- Email: mc-vantyghem@chru-lille.fr
Study Locations
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Lille, France, 59037
- Recruiting
- Hop Claude Huriez Chu Lille
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Principal Investigator:
- Marie-Christine VANTIGHEM, MD,PhD
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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
No older than 85 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
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.
- 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.
- 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:
- 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).
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
Cohorts and Interventions
Group / Cohort |
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the frequency of appearance of Candida yeast strains
Time Frame: Baseline: one session
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the frequency of appearance of Candida yeast strains found in mycological samples from both urinary and oral patients.
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Baseline: one session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Christine VANTYGHEM, MD,PhD, University Hospital, Lille
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)
April 23, 2021
Primary Completion (ANTICIPATED)
April 1, 2026
Study Completion (ANTICIPATED)
April 1, 2026
Study Registration Dates
First Submitted
January 8, 2019
First Submitted That Met QC Criteria
January 8, 2019
First Posted (ACTUAL)
January 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017_36
- 2017-A03135-48 (OTHER: ID-RCB number, ANSM)
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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