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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intraocular Melanoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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fluorescence in situ hybridization

At time of surgery

Intervention Type GENETIC

laboratory biomarker analysis

At time of surgery

Intervention Type OTHER

fine-needle aspiration

At time of surgery

Intervention Type PROCEDURE

therapeutic conventional surgery

At time of surgery

Intervention Type PROCEDURE

Questionnaires

The MINI (a structured psychiatric interview) will be administered to all patients that had a pre or post-operative HADS score for suggestive or probable depression or anxiety. A semi-structured interview would be administered to those patients who had some or full decision regret pre-operatively. After completion of the interview, the MINI, a structured psychiatric interview, will be administered.

Intervention Type OTHER

Other Intervention Names

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Hospital Anxiety and Depression Scale (HADS) Decision Regret Scale The MINI (a structured psychiatric interview)

Eligibility Criteria

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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) \</= 1.5 ml/dl
* AST \</= 2 x normal
* ALT \</= 2 x normal
* Alkaline phosphatase \</= 2 x normal