Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma
NCT ID: NCT00991991
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
5 participants
OBSERVATIONAL
2009-07-31
2016-03-31
Brief Summary
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PURPOSE: This research study is looking at tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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PROSPECTIVE
Interventions
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gene expression analysis
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.
polymerase chain reaction
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.
polymorphism analysis
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.
matrix-assisted laser desorption/ionization time of flight mass spectrometry
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.
medical chart review
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous diagnosis of invasive melanoma
* previous chemotherapy or immunotherapy
* patients who are found to have stage IV disease during workup
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Henry Koon, MD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE1609
Identifier Type: OTHER
Identifier Source: secondary_id
CASE 1609-CC733
Identifier Type: OTHER
Identifier Source: secondary_id
CASE1609
Identifier Type: -
Identifier Source: org_study_id
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