- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020072
Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells
Gene Expression Analysis in Cutaneous T-Cell Lymphoma
RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing better methods to detect, predict, and treat cutaneous T-cell lymphoma.
PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.
Study Overview
Detailed Description
OBJECTIVES:
- Identify gene expression patterns in malignant T cells that can be used to diagnose cutaneous T-cell lymphoma.
- Determine the patterns of gene expression that distinguish normal skin-homing T cells from malignant T cells.
OUTLINE: Patients are stratified by disease (Sezary syndrome vs mycosis fungoides) and prior treatment (yes vs no).
All patients receive a physical examination, and a medical history is taken. Patients with Sezary syndrome undergo leukapheresis. Patients with plaque/tumor stage mycosis fungoides undergo skin biopsy of involved skin. Malignant T cells from blood or skin are then isolated and patterns of gene expression in the malignant T cells are compared to those in normal skin-homing T cells from healthy donors using a "gene chip" (Lymphochip).
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 40 patients (20 per disease stratum) will be accrued for this study within 2 years.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven mycosis fungoides with 2 or more plaques or tumors greater than 1 cm in size OR
Immunologically proven Sezary syndrome with all of the following:
- Erythroderma
- Lymphadenopathy
- T-cell receptor variable beta chain clonality greater than 10% of total lymphocytes by flow cytometry OR
- CD4+CD7- T-cell fraction that represents greater than 10% of CD4+ T cells
PATIENT CHARACTERISTICS:
Age:
- 18 to 85
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- HIV-1 and HTLV-1 negative
- No prior intravenous drug use
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 2 months since prior systemic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 2 months since prior electron beam radiotherapy
Surgery:
- Not specified
Other:
- At least 2 weeks since prior topical therapy
- At least 2 months since prior photopheresis
- At least 2 months since prior psoralen ultraviolet light (PUVA) or ultraviolet B (UVB) therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sam T. Hwang, MD, PhD, NCI - Dermatology Branch
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067694
- NCI-00-C-0068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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