Analysis of Genes Present in Cutaneous T-Cell Lymphoma Cells
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| Official Title: | Gene Expression Analysis in Cutaneous T-Cell Lymphoma |
| Study Start Date: | March 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Sam T. Hwang, MD, PhD | NCI - Dermatology Branch |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00020072 History of Changes |
| Obsolete Identifiers: | NCT00004546 |
| Other Study ID Numbers: | CDR0000067694, NCI-00-C-0068 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cutaneous T-cell non-Hodgkin lymphoma mycosis fungoides/Sezary syndrome |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 16, 2013