T Cell Repertoire Analysis of Immune Mediated Skin Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368784
First received: August 24, 2006
Last updated: June 15, 2011
Last verified: June 2011

August 24, 2006
June 15, 2011
January 2007
November 2011   (final data collection date for primary outcome measure)
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 ]
Peripheral blood will be collected from adults ages 18-55. These samples will then be used for PCR analysis and T cell cloning.
Complete list of historical versions of study NCT00368784 on ClinicalTrials.gov Archive Site
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 ]
characterizing the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides).
Not Provided
Not Provided
 
T Cell Repertoire Analysis of Immune Mediated Skin Diseases
T Cell Repertoire Analysis of Immune Mediated Skin Diseases

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
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.

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).

  • Psoriasis
  • Mycosis Fungoides
Not Provided
  • 1
    Have an immune mediated skin disease, such as psoriasis or mycosis fungoides
  • 2
    Age-Matched Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact: Emanaual Maverakis, MD 916-734-1267 emaverakis@ucdavis.edu
Contact: Jamie Chapman 916-734-1267 jamie.chapman@ucdmc.udavis.edu
United States
 
NCT00368784
200513098-1
No
Emanual Maverakis, MD, University of California Davis
University of California, Davis
Not Provided
Principal Investigator: Emanual Maverakis, MD University of California, Davis
University of California, Davis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP