T Cell Repertoire Analysis of Immune Mediated Skin Diseases - Full Text View

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
Psoriasis Mycosis Fungoides	Phase III

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	T Cell Repertoire Analysis of Immune Mediated Skin Diseases

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Psoriasis Skin Conditions

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Biospecimen Description:

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:	August 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Have an immune mediated skin disease, such as psoriasis or mycosis fungoides
2 Age-Matched Controls

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368784

Contacts

Contact: Jennifer Nava

916-734-1438

jennifer.nava@ucdmc.ucdavis.edu

Locations

United States, California
University of California, Davis Department of Dermatology	Recruiting
Sacramento, California, United States, 95816

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Fu-Tong Liu, M.D.

University of California, Davis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of California Davis ( Fu-Tong Liu, MD )
Study ID Numbers:	200513098-1
Study First Received:	August 24, 2006
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00368784 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Immunoproliferative Disorders
Skin Diseases
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Cutaneous T-cell Lymphoma

Psoriasis
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Skin Diseases, Papulosquamous
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Skin Diseases
Sezary Syndrome
Mycosis Fungoides
Lymphatic Diseases
Neoplasms

Psoriasis
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Skin Diseases, Papulosquamous
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on July 02, 2009