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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
reverse transcriptase-polymerase chain reaction
sentinel lymph node biopsy
Sponsored by
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma (Skin) focused on measuring stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center

Outcomes

Primary Outcome Measures

To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004153
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Procedure
Intervention Name(s)
sentinel lymph node biopsy
Primary Outcome Measure Information:
Title
To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. Gajewski, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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

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