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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00368784
Other study ID # 335144
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2007
Est. completion date November 2020

Study information

Verified date March 2021
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 426
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, Davis Department of Dermatology Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

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