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CompletedNCT00368784Updated May 14, 2025

T Cell Repertoire Analysis of Immune Mediated Skin Diseases

An observational study in Psoriasis and Mycosis Fungoides, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
426
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psoriasis
  • Mycosis Fungoides
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In context

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 426 is above the median of 152 across 150 observational studies indexed under Mycoses.

Browse Mycoses studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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).

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

Exclusion Criteria:

  • are taking immunosuppressive medications, which may interfere with T cell analysis
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
426 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and 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.

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What researchers measure

Primary outcomes

  1. Peripheral blood will be collected from adults ages 18-85.

    These samples will then be used for PCR analysis and T cell cloning.

    Time frame: 2 Years

Secondary outcomes

  1. T cell repertoire

    characterizing the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides).

    Time frame: 2 Years

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Study locations

1 site
  • University of California, Davis Department of Dermatology
    Sacramento, California 95816, United States
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00368784
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Aug 25, 2006
Start date
Jan 2007
Primary completion
Nov 2020
Completion
Nov 2020
Last update
May 14, 2025

Study contacts

Emanual Maverakis, M.D.
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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