Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020072
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Gene Expression Analysis in Cutaneous T-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 plaquetumor 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
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 plaquetumor 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-00-C-0068 | None | None | None |