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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020072 |
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 |
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Lymphoma |
Procedure: laboratory biomarker analysis |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Gene Expression Analysis in Cutaneous T-Cell Lymphoma |
Study Start Date: | March 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunologically proven Sezary syndrome with all of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000067694, NCI-00-C-0068 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00020072 |
Health Authority: | United States: Federal Government |
cutaneous T-cell non-Hodgkin lymphoma mycosis fungoides/Sezary syndrome |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Mycosis Fungoides Mycoses |
Lymphatic Diseases Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |