T Cell Repertoire Analysis of Immune Mediated Skin Diseases

NCT ID: NCT00368784

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

426 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Mycosis Fungoides

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emanual Maverakis, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Davis Department of Dermatology

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

335144

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fresolimumab In Systemic Sclerosis
NCT01284322 COMPLETED PHASE1