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

NCT00991991 | Terminated

• 3 other identifiers: CASE1609P30CA043703CASE 1609-CC733
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage I melanoma; stage II melanoma; stage III melanoma

Outcome Measures

Primary Outcomes (3)

• Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement

  at the time of presentation

• Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement

  at the time of presentation

• Combinations of genetic lesions that correlate with nodal metastasis

  at the time of presentation

Interventions

gene expression analysis GENETIC

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 GENETIC

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 GENETIC

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 OTHER

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 OTHER

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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma. Primary care clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Melanoma

Interventions

Gene Expression Profiling; Polymerase Chain Reaction; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; DNA Fingerprinting

Study Officials

• Henry Koon, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)