Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00991991|
Recruitment Status : Terminated (Not enough tissue for analysis)
First Posted : October 8, 2009
Last Update Posted : May 17, 2016
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.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry Other: medical chart review|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma|
|Study Start Date :||July 2009|
|Primary Completion Date :||March 2016|
|Study Completion Date :||March 2016|
Genetic: gene expression analysis
- Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement [ Time Frame: at the time of presentation ]
- Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement [ Time Frame: at the time of presentation ]
- Combinations of genetic lesions that correlate with nodal metastasis [ Time Frame: at the time of presentation ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991991
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Henry Koon, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|