Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of 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.
Genetic: reverse transcriptase-polymerase chain reaction
Procedure: sentinel lymph node biopsy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma|
- To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 1998|
|Study Completion Date:||January 2005|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004153
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Study Chair:||Thomas F. Gajewski, MD, PhD||University of Chicago|