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

This study has been terminated.
(Not enough tissue for analysis)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00991991
First received: October 7, 2009
Last updated: May 16, 2016
Last verified: May 2016
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement [ Time Frame: at the time of presentation ] [ Designated as safety issue: No ]
  • Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement [ Time Frame: at the time of presentation ] [ Designated as safety issue: No ]
  • Combinations of genetic lesions that correlate with nodal metastasis [ Time Frame: at the time of presentation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma

Enrollment: 5
Study Start Date: July 2009
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Genetic: 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.
    Genetic: 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.
    Other: 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.
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma. Primary care clinic
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991991

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Henry Koon, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00991991     History of Changes
Other Study ID Numbers: CASE1609  P30CA043703  CASE1609  CASE 1609-CC733 
Study First Received: October 7, 2009
Last Updated: May 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
stage I melanoma
stage II melanoma
stage III melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 21, 2016