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CompletedNCT00004153Updated Sep 5, 2013

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

An interventional study of reverse transcriptase-polymerase chain reaction and sentinel lymph node biopsy in Melanoma (Skin), sponsored by University of Chicago. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by University of Chicago · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage I melanoma
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 106 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
106 participants (actual)

Interventions

  • Geneticreverse transcriptase-polymerase chain reaction
  • Proceduresentinel lymph node biopsy
06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

07

Study locations

1 site
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004153
Lead sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jun 1998
Primary completion
Mar 2004
Completion
Jan 2005
Last update
Sep 5, 2013

Study contacts

Thomas F. Gajewski, MD, PhD
study chair · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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