Single Cell Genomics of Psoriatic Skin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand how genetics play a role in psoriasis. Specifically, a genetic allele HLA-Cw6 is known to be associated with psoriasis, and this study aims to find out how it affects genetic and protein expression in patients with psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry and RNA-sequencing protocol.

Official Title
-----------------
Elucidating the Fundamental Differences Between HLA-Cw6 Positive and HLA-Cw6 Negative Psoriasis Skin Lesions, With a Comparison to Healthy Skin, at the Single Cell Level of the Infiltrated Immune Cell Types

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Procedure: Skin biopsy
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For subjects in the psoriasis group: Ability to provide written consent and comply with the protocol At least 18 years of age Diagnosis of plaque psoriasis for at least 6 months prior to enrollment BSA > 5% and at least one target plaque on trunk or extremities greater than 10cm2 For control subjects: Ability to provide written consent and comply with the protocol At least 18 years of age No previous diagnosis of psoriasis or other inflammatory skin conditions Exclusion Criteria: For subjects in the psoriasis group: Subject has non-plaque form of psoriasis. Subject has drug-induced psoriasis. Pregnancy at any point during the study period. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents. Known HIV positive status. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause. Known coagulopathy. For control subjects: Any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions. Pregnancy at any point during the study period. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents. Known HIV positive status. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause. Known coagulopathy. Use of any immunosuppressant or immunomodulating therapies within 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 HLA-Cw6+<br>HLA-Cw6+ patients will donate blood and skin samples | Procedure: Skin biopsy<br>* Four 4-5 mm punch biopsies of the skin<br>Procedure: Blood draw<br>* Blood will be drawn to test for HLA-cw6 status<br>|
| Experimental: 10 HLA Cw6-<br>HLA-Cw6- patients will donate blood and skin samples | Procedure: Skin biopsy<br>* Four 4-5 mm punch biopsies of the skin<br>Procedure: Blood draw<br>* Blood will be drawn to test for HLA-cw6 status<br>|
| Experimental: Healthy Skin<br>Healthy patients will donate blood and skin samples | Procedure: Skin biopsy<br>* Four 4-5 mm punch biopsies of the skin<br>Procedure: Blood draw<br>* Blood will be drawn to test for HLA-cw6 status<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of immune cell population from skin biopsies |  | once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of diferentially expressed genes from skin biopsies |  | once | 
| Determination of HLA -cw6 status from blood samples |  | once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunology, genetics