Analysis of Genes Present in Cutaneous T-Cell Lymphoma Cells - Tabular View

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

February 6, 2009

Start Date ^ICMJE

March 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00020072 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Analysis of Genes Present in Cutaneous T-Cell Lymphoma Cells

Official Title ^ICMJE

Gene Expression Analysis in Cutaneous T-Cell Lymphoma

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Other: laboratory biomarker analysis

Study Arms / Comparison Groups

Publications *

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

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00020072

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067694, NCI-00-C-0068

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Sam T. Hwang, MD, PhD

NCI - Dermatology Branch

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP