Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

Gene Expression Analysis in Cutaneous T-Cell Lymphoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00020072

Enrollment

Unknown

Registered

2003-01-27

Start date

2000-03-31

Completion date

Unknown

Last updated

2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

cutaneous T-cell non-Hodgkin lymphoma, mycosis fungoides/Sezary syndrome

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.

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.

Interventions

OTHERlaboratory biomarker analysis

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026