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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)

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: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.


Detailed Summary:

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.


Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: Feasibility of using FNA and FISH to determine tumor genotype

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • Ophthalmic complication rate of FNA for FISH analysis
  • Disease-free survival with and without tumor monosomy 3 and/or 8q amplification
  • Relationship between biomarkers and the presence of monosomy 3 and/or 8q amplification


Information By: Case Comprehensive Cancer Center

Dates:
Date Received: August 5, 2009
Date Started: March 2009
Date Completion:
Last Updated: January 28, 2015
Last Verified: January 2015