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

The University of Chicago

Status: Completed

Conditions: Melanoma (Skin)

Treatments: Genetic: reverse transcriptase-polymerase chain reaction; Procedure: sentinel lymph node biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004153

9308

UCCRC-9308

UCCRC-CTRC-9767

NCI-G99-1620

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)