T Cell Repertoire Analysis of Immune Mediated Skin Diseases

NCT00368784 | Completed

• 1 other identifier: 335144
• Study Type: observational
• Target: 426
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Peripheral blood will be collected from adults ages 18-85.

  These samples will then be used for PCR analysis and T cell cloning.

  2 Years

Secondary Outcomes (1)

• T cell repertoire

  2 Years

Study Arms (2)

1

Individuals ages 12-85 with an immune mediated skin disease, such as psoriasis, scleroderma, or mycosis fungoides. Peripheral blood and/or check swabs will be collected from participants ages 12- 85 years old. These samples will then be used to characterize the inflammatory cells as described above.

2

Age-Matched Controls without immune mediated skin diseases. Peripheral blood and/or check swabs will be collected from participants ages 12- 85 years old. These samples will then be used to characterize the inflammatory cells as described above.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects aged 18 years to 55 years who have an immune mediated skin disease, such as psoriasis or mycosis fungoides, and age-matched controls (subjects who do not have an immunce midiated skin disease).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

Biospecimen

Retention: SAMPLES WITH DNA

Fifteen tablespoons of blood will be collected prior to the initiation of a treatment and again after the patient shows a clinical response to a 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.

MeSH Terms

Conditions

Psoriasis; Mycosis Fungoides

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Emanual Maverakis, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 25, 2006
• Study Start: January 1, 2007
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: May 14, 2025

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)