Chicago, Illinois 60637

  • Melanoma (Skin)

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.


Study summary:

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.


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


Study is Available At:


Original ID:

9308


NCT ID:

NCT00004153


Secondary ID:

UCCRC-9308


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

106


Enrollment Type:

Actual


Overall Contact Information

Official Name:Thomas F. Gajewski, MD, PhD
Study Chair
University of Chicago

Study Dates

Start Date:June 1998
Completion Date:January 2005
Completion Type:Actual
Primary Completion Date:March 2004
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 4, 2013
First Received Date:December 10, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease
Time Frame:3 years
Safety Issues:False

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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