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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004153
• Other study ID #: 9308
• Secondary ID: UCCRC-9308UCCRC-
• Status: Completed
• Phase: N/A
• First received: December 10, 1999
• Last updated: September 4, 2013
• Start date: June 1998
• Est. completion date: January 2005

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2005
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• reverse transcriptase-polymerase chain reaction

Procedure:
• sentinel lymph node biopsy

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease		3 years	No