NCT04864886 Metabolic Profiling of Immune Responses in Immune-mediated Diseases
| NCT ID | NCT04864886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Primary Immunodeficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-08-10 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2021-08-10 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response. Objective: To learn about how the immune system and skin healing are related to each other. Eligibility: People ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed. Design: Participants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test. Participants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions. Participants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil. Participants will give at least 1 blood sample. Participants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm. Participants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed. Participants may give leftover samples taken as part of their regular medical care. Participation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.
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 OR 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. Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Contact & Investigator
Ian A Myles, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT04864886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Immunodeficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04864886 currently recruiting?
Yes, NCT04864886 is actively recruiting participants. Contact the research team at jodi.blake@nih.gov for enrollment information.
Where is the NCT04864886 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04864886 clinical trial?
NCT04864886 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Ian A Myles, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 300 participants.