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.
Observational
Observational Model: Defined Population, Time Perspective: Longitudinal, Time Perspective: Prospective
J. William Harbour, MD
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
98-0042-A
NCT00406120
January 2007
December 2017
Name | Location |
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Washington University School of Medicine | Saint Louis, Missouri 63110 |