Trial Information

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

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.