Status:
COMPLETED
Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Eligibility:
All Genders
18+ years
Brief 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:...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00952939
Start Date
March 1 2009
End Date
February 1 2014
Last Update
January 30 2015
Active Locations (1)
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1
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States, 44195