Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma
OBJECTIVES:
- Determine the feasibility of performing reverse transcriptase-polymerase chain reaction
(RT-PCR) for five different tumor antigen genes using lymph node samples or peripheral
blood from patients with melanoma.
- Determine the ability of PCR-positive lymph nodes or peripheral blood to predict
relapse of disease in these patients.
- Determine the correlation of positive PCR results from peripheral blood with disease
stage.
OUTLINE: Lymph node biopsies or peripheral blood are obtained from patients. These specimens
are examined by nested reverse transcriptase-polymerase chain reaction (RT-PCR) and analyzed
for various tumor antigens.
Patients may choose to be told the results of this testing, but the results do not influence
or change the planned therapy. Brief counseling is required to discuss the results and their
potential implications.
Patients are followed for at least 2 years.
PROJECTED ACCRUAL: A total of 30 patients for the lymph node portion and 80 patients (20 per
stage of disease) for the peripheral blood portion will be accrued for this study within 3
years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease
3 years
No
Thomas F. Gajewski, MD, PhD
Study Chair
University of Chicago
United States: Federal Government
9308
NCT00004153
June 1998
January 2005
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |