Exploring the Fungal Causes of Autoimmune Polyendocrinopathy Types 1 and 2
Characterization of the Fungal Origins in the Autoimmune Polyendocrinopathy of Type 1 Compared With the Autoimmune Polyendocrinopathies of Type 2
This study is trying to find out how fungal infections affect people with autoimmune polyendocrinopathy types 1 and 2, especially those with APECED, to see if these infections lead to more health problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT03800056 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the fungal origins associated with autoimmune polyendocrinopathy, specifically comparing Type 1 and Type 2 conditions. It focuses on patients with autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED), which is linked to mutations in the AIRE gene. The study will include children and adults, assessing their mycological status and the impact of chronic Candida infections on their health. The goal is to better understand the role of fungal infections in the development of complications such as oral squamous cell carcinomas.
Who should consider this trial
Good fit: Ideal candidates include children aged 0 to 17 and adults between 18 and 85 with a confirmed diagnosis of autoimmune polyendocrinopathy, particularly those with mutations in the AIRE gene.
Not a fit: Patients without a confirmed diagnosis of autoimmune polyendocrinopathy or those who do not meet the age criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of autoimmune polyendocrinopathies, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored the relationship between fungal infections and autoimmune conditions, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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).
Where this trial is running
Lille
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Marie-Christine VANTYGHEM, MD,PhD — University Hospital, Lille
- Study coordinator: Marie-Christine VANTYGHEM, MD,PhD
- Email: mc-vantyghem@chru-lille.fr
- Phone: 320 44 45 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.