Validation of a Molecular Prognostic Test for Eye Melanoma
| Status: | Withdrawn |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/27/2018 |
| Start Date: | May 2007 |
| End Date: | May 2010 |
Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma
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.
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.
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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