NCT00952939

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Intraocular Melanoma

Interventions

Type	Name	Description
GENETIC	fluorescence in situ hybridization	At time of surgery
OTHER	laboratory biomarker analysis	At time of surgery
PROCEDURE	fine-needle aspiration	At time of surgery
PROCEDURE	therapeutic conventional surgery	At time of surgery
OTHER	Questionnaires	The MINI (a structured psychiatric interview) will be administered to all patients that had a pre or post-operative HADS score for suggestive or probable depression or anxiety. A semi-structured interview would be administered to those patients who had some or full decision regret pre-operatively. After completion of the interview, the MINI, a structured psychiatric interview, will be administered.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-09-01
• Completion: 2014-02-01
• First posted: 2009-08-06
• Last updated: 2015-01-30

Locations

1 site across 1 country: United States