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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedDiagnosticCompletedAny ageNCI, Other9308
UCCRC-9308, UCCRC-CTRC-9767, NCI-G99-1620, NCT00004153

Trial Description


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.

Further Study Information


  • 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 Criteria


  • 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



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 7 g/dL


  • PT less than 15 sec
  • PTT less than 30 sec


  • Not specified


  • No psychiatric illness that precludes compliance
  • No other concurrent malignancy


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Chicago Cancer Research Center

  • National Cancer Institute
Thomas F. Gajewski, Study Chair

Link to the current record.
NLM Identifier NCT00004153 processed this data on October 17, 2013

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to