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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00004153
First received: December 10, 1999
Last updated: September 4, 2013
Last verified: September 2013
  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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ]

Enrollment: 106
Study Start Date: June 1998
Study Completion Date: January 2005
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00004153     History of Changes
Other Study ID Numbers: 9308, UCCRC-9308, UCCRC-CTRC-9767, NCI-G99-1620
Study First Received: December 10, 1999
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
stage I melanoma
stage II melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 19, 2014