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Validation of a Molecular Prognostic Test for Eye Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406120
Recruitment Status : Withdrawn (It has come to our attention that the site was not necessary for our research project.)
First Posted : December 4, 2006
Last Update Posted : June 25, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Uveal Neoplasms Choroid Neoplasms Iris Neoplasms Procedure: Fine needle aspiration biopsy

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma
Estimated Study Start Date : May 2007
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Primary Outcome Measures :
  1. Presentation of Primary Tumor to Metastasis [ Time Frame: 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients have uveal melanoma and are being treated wither by enucleation or plaque radiotherapy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406120

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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: J. William Harbour, MD Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine Identifier: NCT00406120     History of Changes
Other Study ID Numbers: 98-0042-A
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Keywords provided by Washington University School of Medicine:
ciliary body
iris melanoma
choroidal melanoma
ciliary body melanoma
uveal melanoma
posterior uveal melanoma
genetic testing
molecular testing
gene expression profiling
Additional relevant MeSH terms:
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Uveal Neoplasms
Choroid Neoplasms
Iris Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Choroid Diseases
Iris Diseases