Molecular Testing

Introduction

Ocular (uveal) melanoma is the most common cancer of the eye and leads to metastatic death in up to half of affected patients. Early identification of uveal melanoma patients at high risk of metastasis could allow these patients to receive preventative systemic therapy to delay or prevent the development of metastasis. Dr. Harbour and his research team at Washington University in St. Louis have developed a unique molecular prognostic test that can be performed on tumor tissue obtained by fine needle biopsy or at the time of eye removal. The Harbour laboratory has published several peer-reviewed articles in the medical literature showing that this molecular test, which is based on gene expression profiling, is superior to other prognostic methods, including monosomy 3, which was the previous standard for molecular testing.

A New Clinical Study

In order for this molecular prognostic test to be eligible to be certified for clinical use, it must be evaluated prospectively in a large number of patients. Therefore, Dr. Harbour and colleagues around the country are collaborating in a multicenter clinical study to evaluate the prognostic test. The Ocular Oncology Service at Washington University is the coordinating center, the Harbour laboratory is the testing site, and Dr. Harbour is the principal investigator for the study. Participating centers will send tumor tissue to the testing center, where it will be processed and analyzed.

Inclusion Criteria

Patients may be eligible for the study if they have been diagnosed with uveal melanoma. Fresh tumor tissue must be available either by fine needle biopsy, local tumor resection, or enucleation (removal of the eye). A separate arm of the study will assess whether the molecular test provides accurate results on formalin-fixed paraffin-embedded tissue in cases where fresh tumor tissue is not available.

Study Registration

This study has been approved by the Human Studies Committee of Washington University. Each participating center must also obtain Human Studies Committee approval from their local Institutional Review Board. All data generated by the study will be kept confidential and stored according to HIPAA guidelines.

Outcome measures

The molecular test results will be assessed for prognostic accuracy by following patients for at least five years. Any complications, metastasis or other adverse events will be reported to the principal investigator. It will be important for patients to obtain metastasis surveillance testing at regular intervals, as directed by their ocular oncologist.