Validation of a Molecular Prognostic Test for Eye Melanoma

NCT00406120 | Withdrawn

• 1 other identifier: 98-0042-A
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveal Neoplasms; Choroid Neoplasms; Iris Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presentation of Primary Tumor to Metastasis

  60 months

Interventions

Fine needle aspiration biopsy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients have uveal melanoma and are being treated wither by enucleation or plaque radiotherapy.

You may qualify if:

• clinical diagnosis of melanoma of the iris, ciliary body and/or choroid
• treatment to include enucleation, radiotherapy or local tumor resection

You may not qualify if:

• evidence of marked tumor necrosis

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• 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. doi: 10.2353/jmoldx.2006.060077.

  PMID: 17065425 BACKGROUND

• 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. doi: 10.1158/0008-5472.CAN-05-4196.

  PMID: 16651410 BACKGROUND

• 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. doi: 10.1016/j.ajo.2005.04.024.

  PMID: 16226537 BACKGROUND

• 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. doi: 10.1159/000326153.

  PMID: 15966293 BACKGROUND

• 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. doi: 10.1158/0008-5472.CAN-04-1750.

  PMID: 15492234 BACKGROUND

MeSH Terms

Conditions

Uveal Neoplasms; Choroid Neoplasms; Iris Neoplasms; Melanoma; Uveal Melanoma; Neoplasm Metastasis

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Eye Neoplasms; Neoplasms by Site; Neoplasms; Eye Diseases; Uveal Diseases; Choroid Diseases; Iris Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• J. William Harbour, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: May 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (1)