Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

OBJECTIVES:

- Correlate degree of melastatin gene expression with risk of developing local regional
metastases in patients with primary stage I or II melanoma.

- Correlate melastatin expression prospectively with event-free survival of these
patients.

OUTLINE: This is a multicenter study.

Melastatin mRNA expression is determined by in situ hybridization using tissue from primary
tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using
antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do
the results influence individual therapy.

Patients are followed every 4 months for 3.5 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

1. Histologically documented primary AJCC stage I or II melanoma. Evidence of
ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular
invasion, microscopic satellitosis, and mitotic rate shall be noted.

2. Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node
dissection of an anatomic draining region from the index primary melanoma.

3. ≥18 years of age

4. Patients must be registered prior to planned surgery. The surgery must be performed
within 45 days following registration.

5. No concurrent active malignancy other than carcinoma in situ of the cervix and basal
cell carcinoma of the skin, or history of any other primary malignancy including
previously primary melanoma.

6. Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow
thickness. Note: If blocks cannot be sent due to institutional policy, slides may be
substituted for the locks per the protocol.