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

Melanoma (Skin) Clinical Trial

Official title:

Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00991991
• Other study ID #: CASE1609
• Secondary ID: P30CA043703CASE1
• Status: Terminated
• Phase: N/A
• First received: October 7, 2009
• Last updated: May 16, 2016
• Start date: July 2009
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement		at the time of presentation	No
Primary	Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement		at the time of presentation	No
Primary	Combinations of genetic lesions that correlate with nodal metastasis		at the time of presentation	No