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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004153

Enrollment

106

Registered

2003-01-27

Start date

1998-06-30

Completion date

2005-01-31

Last updated

2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

Brief summary

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

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.

Interventions

GENETICreverse transcriptase-polymerase chain reaction

PROCEDUREsentinel lymph node biopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026