Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma
NCT ID: NCT00004153
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
1998-06-30
2005-01-31
Brief Summary
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PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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reverse transcriptase-polymerase chain reaction
sentinel lymph node biopsy
Eligibility Criteria
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Inclusion 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
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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Thomas F. Gajewski, MD, PhD
Role: STUDY_CHAIR
University of Chicago
Locations
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University of Chicago Cancer Research Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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UCCRC-9308
Identifier Type: -
Identifier Source: secondary_id
UCCRC-CTRC-9767
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1620
Identifier Type: -
Identifier Source: secondary_id
9308
Identifier Type: -
Identifier Source: org_study_id