RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.
OBJECTIVES: Primary * To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma. Secondary * To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy. * To estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification. * To explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin). * To explore the psychological impact of prognostication in uveal melanoma. OUTLINE: Patients undergo plaque radiotherapy, enucleation, or tumor resection based upon standard of care guidelines. Trans-scleral fine needle aspiration (FNA) is performed at the time of plaque radiotherapy and ex vivo FNA is performed on enucleation and tumor resection specimens. Tissue samples are analyzed by fluorescence in situ hybridization (FISH). Blood samples are also collected for further analysis. After completion of study therapy, patients are followed up periodically.
Study Type
OBSERVATIONAL
Enrollment
150
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States
Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes
DFS will be measured from the date of initial treatment to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier.
Time frame: 2 years
Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
Time frame: 2 years
The rate that sufficient tissue can be obtained by FNA.
Determine if sufficient material for FISH analysis can be obtained by transscleral FNA, a diagnostic procedure performed for a variety of clinical indications in patients with eye abnormalities.
Time frame: 2 yrs
distribution of particular markers at specific timepoints
Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.
Time frame: at baseline, multiple time points up to 2 years
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At time of surgery
The MINI (a structured psychiatric interview) will be administered to all patients that had a pre or post-operative HADS score for suggestive or probable depression or anxiety. A semi-structured interview would be administered to those patients who had some or full decision regret pre-operatively. After completion of the interview, the MINI, a structured psychiatric interview, will be administered.