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

Sponsors and Collaborators:	University of Chicago National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004153

Purpose

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.

Condition	Intervention
Melanoma (Skin)	Genetic: reverse transcriptase-polymerase chain reaction Procedure: sentinel lymph node biopsy

MedlinePlus related topics: Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 1998

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004153

Locations

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

National Cancer Institute (NCI)

Investigators

Study Chair:

Thomas F. Gajewski, MD, PhD

University of Chicago

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067386, UCCRC-9308, UCCRC-CTRC-9767, NCI-G99-1620
Study First Received:	December 10, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004153 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009