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

Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00991991
Enrollment
5
Registered
2009-10-08
Start date
2009-07-31
Completion date
2016-03-31
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage I melanoma, stage II melanoma, stage III melanoma

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

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 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.

Interventions

GENETICgene 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.

GENETICpolymerase 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.

GENETICpolymorphism 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.

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.

OTHERmedical 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvementat the time of presentation
Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvementat the time of presentation
Combinations of genetic lesions that correlate with nodal metastasisat the time of presentation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026