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Validation of a Molecular Prognostic Test for Eye Melanoma

This study has been withdrawn prior to enrollment.
(It has come to our attention that the site was not necessary for our research project.)
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00406120
First received: November 29, 2006
Last updated: May 16, 2007
Last verified: May 2007

November 29, 2006
May 16, 2007
January 2007
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Metastasis
Complete list of historical versions of study NCT00406120 on ClinicalTrials.gov Archive Site
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Complications
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Validation of a Molecular Prognostic Test for Eye Melanoma
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.

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
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  • Uveal Neoplasms
  • Choroid Neoplasms
  • Iris Neoplasms
Procedure: Fine needle aspiration biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
2000
December 2017
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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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00406120
98-0042-A
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Washington University School of Medicine
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Principal Investigator: J. William Harbour, MD Washington University School of Medicine
Washington University School of Medicine
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP