Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Apr 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system affects skin healing in people with immune-related conditions such as primary immunodeficiency, psoriasis, and atopic dermatitis (eczema). Researchers hope to better understand these relationships to improve treatments for these diseases. To participate, individuals aged 18 to 75 who have one of these conditions or are healthy volunteers may be eligible. Participants will need to share their medical history, medications, and skincare routines.

During the study, participants will have a few procedures, including skin biopsies, which involve taking small samples of skin, and providing blood samples. These procedures are designed to gather information about the immune response and skin healing. The entire participation will last about four days, with two visits, each lasting around an hour. Participants will also have the option to provide additional samples from routine medical care for future research. This study is currently looking for volunteers to help advance our understanding of immune-mediated diseases.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 1. Meets one of the following:
• • 1. 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
• • 2. Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators AND a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or
• • 3. Has physician-diagnosed psoriasis; or
• • 4. Has physician-diagnosed AD; or
• • 5. Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers).
• • 2. Aged 18 to 75 years.
• • 3. Willing to allow storage of blood, biopsy tissue, bacterial and fungal cultures, and any other samples collected for future research.
• • 4. Able to provide informed consent.
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).
• • 2. Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.
• • 3. History of keloid formation.
• • 4. Pregnancy, lactating, or breastfeeding.
• • 5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.