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Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma

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Uveal Neoplasms, Choroid Neoplasms, Iris Neoplasms

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Trial Information

Validation of a Molecular Test for Predicting Metastasis in Patients With Uveal 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.

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

Type of Study:


Study Design:

Observational Model: Defined Population, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

J. William Harbour, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

December 2017

Related Keywords:

  • Uveal Neoplasms
  • Choroid Neoplasms
  • Iris Neoplasms
  • 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
  • Neoplasms
  • Choroid Neoplasms
  • Iris Neoplasms
  • Melanoma
  • Uveal Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110