Validation of a Molecular Prognostic Test for Eye Melanoma - Full Text View

Sponsor:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00406120

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:	Longitudinal, Defined Population, Prospective Study
Official Title:	Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma

Resource links provided by NLM:

Genetics Home Reference related topics: retinoblastoma

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Estimated Enrollment:	2000
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2017

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406120

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

J. William Harbour, MD

Washington University School of Medicine

More Information

Additional Information:

Website of Principal Investigator This link exits the ClinicalTrials.gov site

Publications:

Onken MD, Worley LA, Davila RM, Char DH, Harbour JW. Prognostic testing in uveal melanoma by transcriptomic profiling of fine needle biopsy specimens. J Mol Diagn. 2006 Nov;8(5):567-73.

Onken MD, Ehlers JP, Worley LA, Makita J, Yokota Y, Harbour JW. Functional gene expression analysis uncovers phenotypic switch in aggressive uveal melanomas. Cancer Res. 2006 May 1;66(9):4602-9.

Onken MD, Lin AY, Worley LA, Folberg R, Harbour JW. Association between microarray gene expression signature and extravascular matrix patterns in primary uveal melanomas. Am J Ophthalmol. 2005 Oct;140(4):748-9.

Faulkner-Jones BE, Foster WJ, Harbour JW, Smith ME, Davila RM. Fine needle aspiration biopsy with adjunct immunohistochemistry in intraocular tumor management. Acta Cytol. 2005 May-Jun;49(3):297-308.

Onken MD, Worley LA, Ehlers JP, Harbour JW. Gene expression profiling in uveal melanoma reveals two molecular classes and predicts metastatic death. Cancer Res. 2004 Oct 15;64(20):7205-9.

Study ID Numbers:	98-0042-A
Study First Received:	November 29, 2006
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00406120 History of Changes
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:

Uveal Diseases
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Neoplasms, Nerve Tissue
Iris Neoplasms
Choroid Diseases
Uveal Neoplasms
Melanoma

Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Iris Diseases
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Choroid Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010