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| Sponsored by: |
University of California, Davis |
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00368784 |
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.
| Condition | Phase |
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Psoriasis Mycosis Fungoides |
Phase III |
| MedlinePlus related topics: | Fungal Infections Psoriasis Skin Conditions |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | T Cell Repertoire Analysis of Immune Mediated Skin Diseases |
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: | January 2009 |
| Estimated Primary Completion Date: | January 2009 (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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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:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Nava | 916-734-1438 | jennifer.nava@ucdmc.ucdavis.edu |
| United States, California | |||||
| University of California, Davis Department of Dermatology | Recruiting | ||||
| Sacramento, California, United States, 95816 | |||||
| University of California, Davis |
| Principal Investigator: | Fu-Tong Liu, M.D. | University of California, Davis |
More Information
Related Info
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| Responsible Party: | University of California Davis ( Fu-Tong Liu, MD ) |
| Study ID Numbers: | 200513098-1 |
| First Received: | August 24, 2006 |
| Last Updated: | August 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00368784 |
| Health Authority: | United States: Institutional Review Board |
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