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T Cell Repertoire Analysis of Immune Mediated Skin Diseases
This study is currently recruiting participants.
Verified May 2017 by University of California, Davis
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368784
First received: August 24, 2006
Last updated: May 22, 2017
Last verified: May 2017
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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.
| Condition |
|---|
| Psoriasis Mycosis Fungoides |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Control Time Perspective: Prospective |
| Official Title: | T Cell Repertoire Analysis of Immune Mediated Skin Diseases |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | November 2018 |
| Estimated Primary Completion Date: | November 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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 (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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).
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368784
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368784
Contacts
| Contact: Emanaual Maverakis, M.D. | 916-734-1267 | emaverakis@ucdavis.edu | |
| Contact: Victoria Wells | 916-734-1267 | victoria.wells@ucdmc.udavis.edu |
Locations
| United States, California | |
| University of California, Davis Department of Dermatology | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Emanual Maverakis, M.D. 916-734-1267 emaverakis@ucdavis.edu | |
| Contact: Victoria Wells 916-734-1267 victoria.wells@ucdmc.ucdavis.edu | |
| Principal Investigator: Emanual Maverakis, M.D. | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Emanual Maverakis, M.D. | University of California, Davis |
More Information
Additional Information:
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00368784 History of Changes |
| Other Study ID Numbers: |
200513098 |
| Study First Received: | August 24, 2006 |
| Last Updated: | May 22, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Psoriasis Mycoses Mycosis Fungoides Skin Diseases Skin Diseases, Papulosquamous 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 July 25, 2017