ClinicalTrials.gov
ClinicalTrials.gov Menu

T Cell Repertoire Analysis of Immune Mediated Skin Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00368784
Recruitment Status : Recruiting
First Posted : August 25, 2006
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Psoriasis Mycosis Fungoides

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: T Cell Repertoire Analysis of Immune Mediated Skin Diseases
Study Start Date : January 2007
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of California-Davis Department of Dermatology Clinical Research  This link exits the ClinicalTrials.gov site

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00368784     History of Changes
Other Study ID Numbers: 335144
First Posted: August 25, 2006    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
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