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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)

Conditions
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Intraocular Melanoma

Intervention / Treatment
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* Genetic: fluorescence in situ hybridization
* Other: laboratory biomarker analysis
* Procedure: fine-needle aspiration
* Procedure: therapeutic conventional surgery
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids Patients must have had a hepatic ultrasound and/or other suitable imaging studies to eliminate metastatic disease Patients must not have received any local or systemic therapy for uveal melanoma All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. A copy of the informed consent document signed by the patient must be given to the patient Patients must have the following pretreatment laboratory findings: Bilirubin (total) </= 1.5 ml/dl AST </= 2 x normal ALT </= 2 x normal Alkaline phosphatase </= 2 x normal Exclusion Criteria Patients with metastasis Patients under the age of 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: fluorescence in situ hybridization|At time of surgery|
|Other: laboratory biomarker analysis|At time of surgery|
|Procedure: fine-needle aspiration|At time of surgery|
|Procedure: therapeutic conventional surgery|At time of 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | at baseline, multiple time points up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ciliary body and choroid melanoma, small size, iris melanoma, intraocular melanoma, ciliary body and choroid melanoma, medium/large size