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OpenTrials
Completed

NCT Number: NCT00020072

Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Gene Expression Analysis in Cutaneous T-Cell Lymphoma

Important dates

Study start
2000
First posted
Jan 27, 2003
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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