Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

Lymphoma Clinical Trial

Official title:

Gene Expression Analysis in Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020072
• Other study ID #: CDR0000067694
• Secondary ID: NCI-00-C-0068
• Status: Completed
• Phase: N/A
• First received: July 11, 2001
• Last updated: April 28, 2015
• Start date: March 2000

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00004546

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hwang ST, Fitzhugh DJ. Aberrant expression of adhesion molecules by Sézary cells: functional consequences under physiologic shear stress conditions. J Invest Dermatol. 2001 Mar;116(3):466-70. — View Citation