Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020072
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2015
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma Other: laboratory biomarker analysis Not Applicable

Detailed Description:


  • 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 : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Official Title: Gene Expression Analysis in Cutaneous T-Cell Lymphoma
Study Start Date : March 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 85

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • HIV-1 and HTLV-1 negative
  • No prior intravenous drug use


Biologic therapy:

  • Not specified


  • At least 2 months since prior systemic chemotherapy

Endocrine therapy:

  • Not specified


  • At least 2 months since prior electron beam radiotherapy


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020072

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Sam T. Hwang, MD, PhD NCI - Dermatology Branch

Publications of Results: Identifier: NCT00020072     History of Changes
Obsolete Identifiers: NCT00004546
Other Study ID Numbers: CDR0000067694
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
cutaneous T-cell non-Hodgkin lymphoma
mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin