T Cell Repertoire Analysis of Immune Mediated Skin Diseases

Completed

• Conditions: Psoriasis; Mycosis Fungoides

• Registration Number: NCT00368784
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-25
• Study Start: 2007-01
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2021-03
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of California, Davis Department of Dermatology; 🇺🇸 Sacramento, California, United States