Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye
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|ClinicalTrials.gov Identifier: NCT00952939|
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : January 30, 2015
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.
|Condition or disease||Intervention/treatment|
|Intraocular Melanoma||Genetic: fluorescence in situ hybridization Other: laboratory biomarker analysis Procedure: fine-needle aspiration Procedure: therapeutic conventional surgery Other: Questionnaires|
- To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma.
- 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|
|Actual Enrollment :||150 participants|
|Official Title:||Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||February 2014|
Genetic: fluorescence in situ hybridization
- Hospital Anxiety and Depression Scale (HADS)
- Decision Regret Scale
- The MINI (a structured psychiatric interview)
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952939
|United States, Ohio|
|Cleveland Clinic Cole Eye Institute|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Arun D. Singh, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|