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



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:July 2009

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Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma

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 tissue samples from patients with stage I,
stage II, or stage III malignant melanoma.

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 melanoma development, and 2) allelic imbalances across the genome.

- Compare the genetic profile of primary melanomas from patients with and without lymph
node involvement.

- Determine the combinations of genetic lesions that correlate with nodal metastasis by
adopting a statistical machine learning approach to build a lesion-based classifier for
nodal metastasis.

OUTLINE: Laser capture microdissection is performed on the archived tissue samples to
isolate melanoma cells. DNA is then purified from the samples and amplified using PCR.
Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry
technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism
arrays are also performed.

Information about the patient's demographics (e.g., TNM staging, sex, age, and tissue
collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma
Conference at University Hospitals tumor conference report in order to match cases.

Inclusion Criteria:

- 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 Criteria:

- Acral and mucosal histology

- Previous diagnosis of invasive melanoma

- previous chemotherapy or immunotherapy

- patients who are found to have stage IV disease during workup
We found this trial at
1
site
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Phone: 216-368-1175
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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Cleveland, OH
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