Status:

TERMINATED

Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma

Lead Sponsor:

Case Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

Brief Summary

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor t...

Detailed Description

OBJECTIVES: * Determine the genetic profile of primary melanomas with and without synchronous regional nodal involvement by examining for 1) activating mutations B-Raf and N-Ras associated with melan...

Eligibility Criteria

Inclusion

  • Node positive Group (experimental group)
  • Primary melanoma \> 2 mm in depth
  • Metastasis must be \> 0.1 mm and detectable by IHC or hematoxylin and eosin (H\&E) to be considered node positive
  • Slides and block for primary and node must be archived in UH dermatopathology
  • Node Negative Group (control group)
  • Primary melanoma \> 2 mm in depth
  • A negative sentinel lymph node must be negative by IHC and H\&E
  • No stage IV disease
  • No acral and mucosal histology
  • No history of prior invasive melanoma
  • Underwent primary excision and sentinel lymph node biopsy within 3 months of each other
  • Archived tissue available
  • Slides and block for primary tumor and node biopsy must be archived in University Hospitals Case Medical Center (UH) dermatopathology

Exclusion

  • Acral and mucosal histology
  • Previous diagnosis of invasive melanoma
  • previous chemotherapy or immunotherapy
  • patients who are found to have stage IV disease during workup

Key Trial Info

Start Date :

July 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2016

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT00991991

Start Date

July 1 2009

End Date

March 1 2016

Last Update

May 17 2016

Active Locations (1)

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1

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106