Status:
RECRUITING
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Primary Immunodeficiency
Psoriasis
Eligibility:
All Genders
18-75 years
Brief Summary
Background: The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficul...
Detailed Description
Study Description: This is an exploratory sample collection study enrolling adult healthy volunteers and patients with immune-mediated diseases to elucidate the metabolic signatures associated with i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Meets one of the following:
- Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or
- Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators OR a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or
- Has physician-diagnosed psoriasis; or
- Has physician-diagnosed AD; or
- Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers).
- Aged 18 to 75 years.
- Willing to allow storage of blood, biopsy tissue, bacterial and fungal cultures, and any other samples collected for future research.
- Able to provide informed consent.
- EXCLUSION CRITERIA:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).
- Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.
- History of keloid formation.
- Pregnancy, lactating, or breastfeeding.
- Any condition that, in the opinion of the investigator, contraindicates participation in the study.
Exclusion
Key Trial Info
Start Date :
August 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04864886
Start Date
August 10 2021
End Date
June 30 2027
Last Update
January 9 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892