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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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    Cleveland Clinic Cole Eye Institute

    Cleveland, Ohio, United States, 44195