T Cell Repertoire Analysis of Immune Mediated Skin Diseases
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ClinicalTrials.gov Identifier: NCT00368784 |
Recruitment Status :
Completed
First Posted : August 25, 2006
Last Update Posted : March 5, 2021
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Condition or disease |
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Psoriasis Mycosis Fungoides |
Study Type : | Observational |
Actual Enrollment : | 426 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | T Cell Repertoire Analysis of Immune Mediated Skin Diseases |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | November 2020 |
Actual Study Completion Date : | November 2020 |

Group/Cohort |
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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.
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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.
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- Peripheral blood will be collected from adults ages 18-85. [ Time Frame: 2 Years ]These samples will then be used for PCR analysis and T cell cloning.
- T cell repertoire [ Time Frame: 2 Years ]characterizing the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides).
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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368784
United States, California | |
University of California, Davis Department of Dermatology | |
Sacramento, California, United States, 95816 |
Principal Investigator: | Emanual Maverakis, M.D. | University of California, Davis |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00368784 |
Other Study ID Numbers: |
335144 |
First Posted: | August 25, 2006 Key Record Dates |
Last Update Posted: | March 5, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Mycoses Mycosis Fungoides Psoriasis Skin Diseases Skin Diseases, Papulosquamous Bacterial Infections and Mycoses Infections 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 |