Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Genetic: reverse transcriptase-polymerase chain reaction
* Procedure: sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Clinically proven melanoma with indication to perform sentinel lymph node biopsy or elective lymph node dissection OR Histologically proven or diagnosis highly suspicious for melanoma PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count greater than 50,000/mm^3 Hemoglobin greater than 7 g/dL Hepatic: PT less than 15 sec PTT less than 30 sec Renal: Not specified Other: No psychiatric illness that precludes compliance No other concurrent malignancy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Procedure: sentinel lymph node biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma