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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00991991
First received: October 7, 2009
Last updated: September 18, 2014
Last verified: September 2014
  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


Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Primary Completion Date: September 2015 (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

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

DISEASE CHARACTERISTICS:

  • Diagnosis of primary melanoma, meeting one of the following 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

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or immunotherapy
  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 Recruiting
Cleveland, Ohio, United States, 44106
Contact: Henry Koon, MD    216-368-1175    henry.koon@case.edu   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Henry Koon, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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: September 18, 2014
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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 25, 2014