Validation of a Molecular Prognostic Test for Eye Melanoma

Study Overview
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Brief Summary
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Up to half of patients with ocular melanoma (also called iris, choroidal or uveal melanoma) develop metastasis. We have found that certain molecular features of the eye tumor can be detected by gene expression profiling and accurately predict which patients will develop metastasis. This molecular test could eventually allow high risk patients to receive preventative therapy to delay or prevent the development of metastasis. The goal of this study is to prospectively validate the predictive accuracy of the gene expression-based molecular test and compare it to monosomy 3, the most common but potentially less accurate molecular marker for metastasis in ocular melanoma.

Detailed Description
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We have discovered a gene expression profile derived from primary uveal melanomas that accurately predicts which patients will develop metastasis. Tumors with a class 1 gene expression signature have a very low risk, and those with a class 2 signature have a high risk of metastasis. The molecular test was initially performed on tissue obtained from enucleated eyes using commercial microarray platforms. We are now able to perform the molecular test on fine needle biopsy specimens, and we have developed a customized test that has greater dynamic range and sensitivity than commercial microarray platforms. The goal of this study is to validate the prognostic accuracy of the customized platform by performing the molecular test on primary uveal melanomas obtained from enucleation, local tumor resection or fine needle biopsy. Each sample will be diagnosed as either class 1, class 2 or indeterminate. Outcomes will be collected and the ability of the molecular diagnosis to predict metastasis will be evaluated at regular intervals.

Official Title
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Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma

Conditions
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Uveal Neoplasms, Choroid Neoplasms, Iris Neoplasms

Intervention / Treatment
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* Procedure: Fine needle aspiration biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of melanoma of the iris, ciliary body and/or choroid treatment to include enucleation, radiotherapy or local tumor resection Exclusion Criteria: evidence of marked tumor necrosis
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 |
| --- |
|Procedure: Fine needle aspiration biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presentation of Primary Tumor to Metastasis |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye, uvea, iris, choroid, ciliary body, melanoma, iris melanoma, choroidal melanoma, ciliary body melanoma, uveal melanoma, posterior uveal melanoma, prognosis, metastasis, genetic testing, molecular testing, gene expression profiling