Melanoma (Skin) Clinical Trial
Official title:
Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma
RATIONALE: Diagnostic procedures may improve the ability to detect the presence or
recurrence of disease.
PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood
of patients who have 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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