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Clinical Trial Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.


Clinical Trial Description

OBJECTIVES:

Primary

- To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma.

Secondary

- To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.

- To estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification.

- To explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin).

- To explore the psychological impact of prognostication in uveal melanoma.

OUTLINE: Patients undergo plaque radiotherapy, enucleation, or tumor resection based upon standard of care guidelines.

Trans-scleral fine needle aspiration (FNA) is performed at the time of plaque radiotherapy and ex vivo FNA is performed on enucleation and tumor resection specimens. Tissue samples are analyzed by fluorescence in situ hybridization (FISH). Blood samples are also collected for further analysis.

After completion of study therapy, patients are followed up periodically. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00952939
Study type Observational
Source Case Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date February 2014

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