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

January 28, 2015 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intraocular Melanoma

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care Clinic

Description

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

Exclusion Criteria

Patients with metastasis
Patients under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes Time Frame: 2 years	DFS will be measured from the date of initial treatment to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy. Time Frame: 2 years	To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.	2 years
The rate that sufficient tissue can be obtained by FNA. Time Frame: 2 yrs	Determine if sufficient material for FISH analysis can be obtained by transscleral FNA, a diagnostic procedure performed for a variety of clinical indications in patients with eye abnormalities.	2 yrs
distribution of particular markers at specific timepoints Time Frame: at baseline, multiple time points up to 2 years	Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.	at baseline, multiple time points up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Arun D. Singh, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria