Validation of a Molecular Prognostic Test for Eye Melanoma

ID: NCT00406120
Status: Withdrawn
Phase: N/A
Start Date: January 01, 2007
First Submitted: November 29, 2006
Last Updated: May 16, 2007
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Uveal Neoplasms, Choroid Neoplasms, Iris Neoplasms
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Choroid Neoplasms

Iris Neoplasms

Uveal Neoplasms

Procedure: Fine needle aspiration biopsy
Other Names
N/A

Tracking Information

First Submitted DateNovember 29, 2006
Last Update Posted DateMay 16, 2007
Start DateJanuary 01, 2007
Anticipated Completion DateDecember 01, 2017
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleValidation of a Molecular Prognostic Test for Eye Melanoma
Official TitleValidation of a Molecular Test for Predicting Metastasis in Patients With Uveal Melanoma
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.

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.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
2000
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Choroid Neoplasms
Iris Neoplasms
Uveal Neoplasms
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Procedure: Fine needle aspiration biopsy

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Withdrawn
Enrollment2000
Completion DateDecember 01, 2017
Eligibility 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
GenderAll
Age N/A to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00406120
Other Study ID Numbers
98-0042-A
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
J. William Harbour, MD
Washington University School of Medicine