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

Sponsor:	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:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	T Cell Repertoire Analysis of Immune Mediated Skin Diseases

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

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

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
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: Emanaual Maverakis, MD	916-734-1267	emaverakis@ucdavis.edu
Contact: Jamie Chapman	916-734-1267	jamie.chapman@ucdmc.udavis.edu

Locations

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

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Emanual Maverakis, MD

University of California, Davis

More Information

Additional Information:

Dermatology Clinical Research This link exits the ClinicalTrials.gov site

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:

Mycoses
Mycosis Fungoides
Psoriasis
Skin Diseases
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
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 09, 2012