Validation of a Molecular Prognostic Test for Eye Melanoma
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Uveal Neoplasms Choroid Neoplasms Iris Neoplasms |
Procedure: Fine needle aspiration biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma |
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2017 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | J. William Harbour, MD | Washington University School of Medicine |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00406120 History of Changes |
| Other Study ID Numbers: | 98-0042-A |
| Study First Received: | November 29, 2006 |
| Last Updated: | May 16, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
eye uvea iris choroid ciliary body melanoma iris melanoma choroidal melanoma |
ciliary body melanoma uveal melanoma posterior uveal melanoma prognosis metastasis genetic testing molecular testing gene expression profiling |
Additional relevant MeSH terms:
|
Neoplasms Choroid Neoplasms Iris Neoplasms Melanoma Uveal Neoplasms Eye Neoplasms Neoplasms by Site Eye Diseases Choroid Diseases |
Uveal Diseases Iris Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 23, 2013