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

Tracking Information

First Received Date ^ICMJE

December 10, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

June 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Melanoma (Skin)

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004153

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067386, UCCRC-9308, UCCRC-CTRC-9767, NCI-G99-1620

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Thomas F. Gajewski, MD, PhD

University of Chicago

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP