Intraocular Melanoma Clinical Trial
Official title:
Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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