RightFit
RecruitingPhase not listed

Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Metabolic Profiling of Immune Responses in Immune-Mediated Diseases

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 4 days
  • Procedures mentioned: Physical exams, Biopsies, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will be screened with a medical and medicine history and a physical exam."
  • "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."
  • "Participants will give at least 1 blood sample."
  • "Participation will last for about 4 days."
  • "Participants will have 2 visits that each last about 1 hour."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the immune system, which fights infections, is linked to skin healing. It is for adults ages 18–75 with certain immune system problems, eczema, or psoriasis, and for healthy volunteers. Participants give blood and small skin samples during two visits over about 4 days.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–75 years old.
  • Have a confirmed or suspected primary immune deficiency, a problem with the body's infection defenses; doctor-diagnosed eczema or psoriasis; or qualify as a healthy volunteer.
  • For immune deficiency: have certain gene changes or a history of infections that happen more often, last longer, or are more severe than normal.
  • For healthy volunteers: have no clear signs of an immune problem caused by one or two genes, eczema, or psoriasis.
  • Agree to let researchers store blood, skin, and other samples for future research.
  • Be able to understand the study and give consent.

Who can't join

  • Use or have used blood-thinning or anti-clotting medicines within the past 3 months. Aspirin and nonsteroidal anti-inflammatory drugs, such as ibuprofen, are allowed.
  • Use or have used medicines that change immune activity, such as chemotherapy or steroids, within the past 3 months, unless the lead researcher approves.
  • Have a history of keloids, which are thick, raised scars.
  • Be pregnant, making breast milk, or breastfeeding.
  • Have any condition that the researcher believes makes participation unsafe or unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD