Validation of a Molecular Prognostic Test for Eye Melanoma

Withdrawn

• Conditions: Choroid Neoplasms; Iris Neoplasms; Uveal Neoplasms

• Registration Number: NCT00406120
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-12-04
• Study Start: 2007-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presentation of Primary Tumor to Metastasis	60 months

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States