Clinical trial NCT00991991: Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma
Official title: Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma (Skin)
Keywords: stage I melanoma
stage II melanoma
stage III melanoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-08
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma. Primary care clinic

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.

Eligibility 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

Primary outcomes:
measure: Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
timeFrame: at the time of presentation
measure: Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
timeFrame: at the time of presentation
measure: Combinations of genetic lesions that correlate with nodal metastasis
timeFrame: at the time of presentation
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Henry Koon, MD
role: PRINCIPAL_INVESTIGATOR
References: