Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye

• Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  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.
  
  

• Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
  
  
• The rate that sufficient tissue can be obtained by FNA. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  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.
  
  
• distribution of particular markers at specific timepoints [ Time Frame: at baseline, multiple time points up to 2 years ] [ Designated as safety issue: No ]
  Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.
  
  

Genetic: fluorescence in situ hybridization
At time of surgery
Other Name: fluorescence in situ hybridization
Other: laboratory biomarker analysis
At time of surgery
Other Name: laboratory biomarker analysis
Procedure: fine-needle aspiration
At time of surgery
Other Name: fine-needle aspiration
Procedure: therapeutic conventional surgery
At time of surgery
Other Name: therapeutic conventional surgery
Other: Questionnaires
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.
Other Names:
• Hospital Anxiety and Depression Scale (HADS)
• Decision Regret Scale
• The MINI (a structured psychiatric interview)

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.