RECRUITING

Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Metabolic Profiling of Immune Responses in Immune-Mediated Diseases

Quick Facts

Study Start:2021-08-10
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04864886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Meets one of the following:
  2. 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
  3. 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
  4. 3. Has physician-diagnosed psoriasis; or
  5. 4. Has physician-diagnosed AD; or
  6. 5. Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers).
  7. 2. Aged 18 to 75 years.
  8. 3. Willing to allow storage of blood, biopsy tissue, bacterial and fungal cultures, and any other samples collected for future research.
  9. 4. Able to provide informed consent.
  1. 1. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).
  2. 2. Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.
  3. 3. History of keloid formation.
  4. 4. Pregnancy, lactating, or breastfeeding.
  5. 5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.

Contacts and Locations

Study Contact

Jodi L Blake, R.N.
CONTACT
(301) 605-2896
jodi.blake@nih.gov
Ian A Myles, M.D.
CONTACT
(301) 451-8420
mylesi@niaid.nih.gov

Principal Investigator

Ian A Myles, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Ian A Myles, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-10
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-08-10
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Primary Immunodeficiency
  • Psoriasis
  • Atopic Dermatitis
  • pathways
  • Natural History

Additional Relevant MeSH Terms

  • Primary Immunodeficiency
  • Psoriasis
  • Atopic Dermatitis
  • Immune-mediated Diseases