Melanoma Clinical Trial

Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria

Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids
Patients must have had a hepatic ultrasound and/or other suitable imaging studies to eliminate metastatic disease
Patients must not have received any local or systemic therapy for uveal melanoma
All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. A copy of the informed consent document signed by the patient must be given to the patient

Patients must have the following pretreatment laboratory findings:

Bilirubin (total) AST ALT Alkaline phosphatase
Exclusion Criteria

Patients with metastasis
Patients under the age of 18

Study is for people with:

Melanoma

Estimated Enrollment:

150

Study ID:

NCT00952939

Recruitment Status:

Completed

Sponsor:

Case Comprehensive Cancer Center

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There is 1 Location for this study

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Cleveland Clinic Cole Eye Institute
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

150

Study ID:

NCT00952939

Recruitment Status:

Completed

Sponsor:


Case Comprehensive Cancer Center

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