T Cell Repertoire Analysis of Immune Mediated Skin Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00368784

Enrollment

426

Registered

2006-08-25

Start date

2007-01-31

Completion date

2020-11-30

Last updated

2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycosis Fungoides, Psoriasis

Brief summary

This study is designed to identify the cells of the immune system that cause skin disease such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in hopes of finding common cells and molecules responsible for skin diseases. Results of this study will increase our knowledge about immune mediated skin disease.

Detailed description

The aim of the study is to characterized the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides). Peripheral blood with be collected from volunteers with psoriasis, mycosis fungoides and age matched controls. Fifteen tablespoons of blood will be collected prior to the initiation of treatment and again after the patient shows a clinical response to treatment. The time between blood draws will be no less than 3 months. There will be no more than two blood draws per patient. Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the patient's haplotype has been established the activated T cell repertoire will be analyzed for clonal expansions. Clonal expansions in the T cell repertoire will be determined by immunoscope analysis, which is a PCR based technique.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Have an immune mediated skin disease, such as psoriasis or mycosis fungoides * Are not taking immunosuppressive medications, which may interfere with T cell analysis.

Exclusion criteria

* are taking immunosuppressive medications, which may interfere with T cell analysis

Design outcomes

Primary

Measure	Time frame	Description
Peripheral blood will be collected from adults ages 18-85.	2 Years	These samples will then be used for PCR analysis and T cell cloning.

Secondary

Measure	Time frame	Description
T cell repertoire	2 Years	characterizing the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides).

Countries

United States

Outcome results