T Cell Repertoire Analysis of Immune Mediated Skin Diseases
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | T Cell Repertoire Analysis of Immune Mediated Skin Diseases |
- Peripheral blood will be collected from adults ages 18-55. These samples will then be used for PCR analysis and T cell cloning. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- characterizing the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Have an immune mediated skin disease, such as psoriasis or mycosis fungoides
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2
Age-Matched Controls
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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).
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
Contacts and Locations| Contact: Emanaual Maverakis, MD | 916-734-1267 | emaverakis@ucdavis.edu |
| Contact: Jamie Chapman | 916-734-1267 | jamie.chapman@ucdmc.udavis.edu |
| United States, California | |
| University of California, Davis Department of Dermatology | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Emanual Maverakis, MD 916-734-1267 emaverakis@ucdavis.edu | |
| Principal Investigator: | Emanual Maverakis, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Emanual Maverakis, MD, University of California Davis |
| ClinicalTrials.gov Identifier: | NCT00368784 History of Changes |
| Other Study ID Numbers: | 200513098-1 |
| Study First Received: | August 24, 2006 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
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Skin Diseases Skin Diseases, Papulosquamous Mycoses Mycosis Fungoides Psoriasis Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013