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Natural History of Individuals With Immune System Problems That Lead to Fungal Infections

NCT01386437 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

\- The immune system is made up of special cells, tissues, and organs that fight infections. Problems with this system may lead to frequent, severe, or unusual fungal infections. These infections are often difficult to treat. Researchers want to collect blood and tissue samples from people who have unusual, persistent or severe fungal infections or immune problems that increase the risk of these infections.

Objectives:

\- To collect medical information and samples for a long-term study of people with immune system problems that lead to fungal infections.

Eligibility:

* People with a history of fungal infections caused by immune system problems.
* Parents, children, and siblings of this group.
* Healthy volunteers not related to the first two groups.

Design:

* This long-term study may last for up to 25 years. Those in the study may need to provide new information about every 6 months. The procedures for each person may vary with the particular diagnosis and the extent of fungal infection. Healthy volunteers may have only one or two visits.
* At the first visit, those in the study will have a full medical history and physical exam. They will also provide blood.
* Research procedures may include the following:
* Saliva, urine or stool testing
* Mouthwash collection for DNA testing
* Collection of cheek cells, nail clippings, or vaginal fluid
* Tests of leftover tissue or body fluid from previous medical procedures
* Skin or oral mucous membrane biopsy
* Collection of white blood cells
* Followup visits will involve a physical exam and updated medical history. Blood, saliva, urine, or nail clipping samples may be taken for ongoing studies. Any additional tests or exams required by the study doctors may also be done.
* Participants may withdraw from the study pool at any time....

Conditions

  • Chronic Mucocutaneous Candidiasis
  • Invasive Aspergillosis
  • CARD9
  • APECED

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michail S Lionakis, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
1 Day
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386437 on ClinicalTrials.gov