Know Cancer

or
forgot password

Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma


N/A
N/A
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

at the time of presentation

Safety Issue:

No

Principal Investigator

Henry Koon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

CASE1609

NCT ID:

NCT00991991

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage I melanoma
  • stage II melanoma
  • stage III melanoma
  • Melanoma

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065