Single Cell Genomics of Psoriatic Skin

NCT ID: NCT02929745

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2020-12-09

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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10 HLA-Cw6+

HLA-Cw6+ patients will donate blood and skin samples

Group Type EXPERIMENTAL

Skin biopsy

Intervention Type PROCEDURE

Four 4-5 mm punch biopsies of the skin

Blood draw

Intervention Type PROCEDURE

Blood will be drawn to test for HLA-cw6 status

10 HLA Cw6-

HLA-Cw6- patients will donate blood and skin samples

Group Type EXPERIMENTAL

Skin biopsy

Intervention Type PROCEDURE

Four 4-5 mm punch biopsies of the skin

Blood draw

Intervention Type PROCEDURE

Blood will be drawn to test for HLA-cw6 status

Healthy Skin

Healthy patients will donate blood and skin samples

Group Type EXPERIMENTAL

Skin biopsy

Intervention Type PROCEDURE

Four 4-5 mm punch biopsies of the skin

Blood draw

Intervention Type PROCEDURE

Blood will be drawn to test for HLA-cw6 status

Interventions

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Skin biopsy

Four 4-5 mm punch biopsies of the skin

Intervention Type PROCEDURE

Blood draw

Blood will be drawn to test for HLA-cw6 status

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

For subjects in the psoriasis group:

1. Ability to provide written consent and comply with the protocol
2. At least 18 years of age
3. Diagnosis of plaque psoriasis for at least 6 months prior to enrollment
4. BSA \> 5% and at least one target plaque on trunk or extremities greater than 10cm2

For control subjects:

1. Ability to provide written consent and comply with the protocol
2. At least 18 years of age
3. No previous diagnosis of psoriasis or other inflammatory skin conditions

Exclusion Criteria

For subjects in the psoriasis group:

1. Subject has non-plaque form of psoriasis.
2. Subject has drug-induced psoriasis.
3. Pregnancy at any point during the study period.
4. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
5. Known HIV positive status.
6. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
7. Known coagulopathy.

For control subjects:

1. Any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions.
2. Pregnancy at any point during the study period.
3. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
4. Known HIV positive status.
5. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
6. Known coagulopathy.
7. Use of any immunosuppressant or immunomodulating therapies within 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilson Liao, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Psoriasis Center

San Francisco, California, United States

Site Status

Countries

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United States

References

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Liu J, Chang HW, Huang ZM, Nakamura M, Sekhon S, Ahn R, Munoz-Sandoval P, Bhattarai S, Beck KM, Sanchez IM, Yang E, Pauli M, Arron ST, Fung-Leung WP, Munoz E, Liu X, Bhutani T, North J, Fourie AM, Rosenblum MD, Liao W. Single-cell RNA sequencing of psoriatic skin identifies pathogenic Tc17 cell subsets and reveals distinctions between CD8+ T cells in autoimmunity and cancer. J Allergy Clin Immunol. 2021 Jun;147(6):2370-2380. doi: 10.1016/j.jaci.2020.11.028. Epub 2020 Dec 9.

Reference Type BACKGROUND
PMID: 33309739 (View on PubMed)

Other Identifiers

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15-17769

Identifier Type: -

Identifier Source: org_study_id

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