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Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma focused on measuring cutaneous T-cell non-Hodgkin lymphoma, mycosis fungoides/Sezary syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020072
Brief Title
Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells
Official Title
Gene Expression Analysis in Cutaneous T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
cutaneous T-cell non-Hodgkin lymphoma, mycosis fungoides/Sezary syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam T. Hwang, MD, PhD
Organizational Affiliation
NCI - Dermatology Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11231324
Citation
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. doi: 10.1046/j.1523-1747.2001.01282.x.
Results Reference
result

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Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

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