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 immune-mediated diseases. We hypothesize that activation of, and responses to, specific immune pathways will require metabolic changes within cells, serum, and skin.
Following screening and baseline procedures, including blood draw, participants will undergo skin biopsies. The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, optionally followed by 1 or 2 punch biopsies 3 (+/-1) days later using a 3-mm punch to encompass the initial biopsy site(s), capturing the tissue at 3 days of healing. In addition, skin swabs and tape strips may be collected to assess for microbial or host markers of epithelial repair. Peripheral blood will be collected with the initial biopsies to compare metabolic signatures in peripheral blood cells and serum with those in the skin. After day 1 (or 3, if the participant has that optional visit), participation in the study will be complete. Samples and data will be stored for future research use.
Objectives:
Primary Objectives:
1. Evaluate metabolic profiles in immune activation associated with known or suspected immune-mediated disorders.
2. Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT), that are associated with immune-mediated disorders.
Secondary Objectives:
Not applicable.
Endpoints:
Primary Endpoints:
1. Fold differences in metabolic pathways associated with immune pathways.
2. Fold differences in metabolic pathways related to wound healing.
3. Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune-mediated disorders.
Secondary Endpoints:
Not applicable.
This is an exploratory sample collection study enrolling adult healthy volunteers and patients with immune-mediated diseases to elucidate the metabolic signatures associated with immune-mediated diseases. We hypothesize that activation of, and responses to, specific immune pathways will require metabolic changes within cells, serum, and skin.
Following screening and baseline procedures, including blood draw, participants will undergo skin biopsies. The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, optionally followed by 1 or 2 punch biopsies 3 (+/-1) days later using a 3-mm punch to encompass the initial biopsy site(s), capturing the tissue at 3 days of healing. In addition, skin swabs and tape strips may be collected to assess for microbial or host markers of epithelial repair. Peripheral blood will be collected with the initial biopsies to compare metabolic signatures in peripheral blood cells and serum with those in the skin. After day 1 (or 3, if the participant has that optional visit), participation in the study will be complete. Samples and data will be stored for future research use.
Objectives:
Primary Objectives:
1. Evaluate metabolic profiles in immune activation associated with known or suspected immune-mediated disorders.
2. Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT), that are associated with immune-mediated disorders.
Secondary Objectives:
Not applicable.
Endpoints:
Primary Endpoints:
1. Fold differences in metabolic pathways associated with immune pathways.
2. Fold differences in metabolic pathways related to wound healing.
3. Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune-mediated disorders.
Secondary Endpoints:
Not applicable.
Visit ClinicalTrials.gov for details.
Contact Information
Office/Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone: 800-411-1222
TTY: TTY8664111010
Email: prpl@cc.nih.gov