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

Not Applicable

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00004153
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-03
• Study Completion: 2005-01
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States