New Biopsy Technique for Uveal Melanoma

Completed

• Conditions: Uveal Melanoma

• Registration Number: NCT01924923
• Lead Sponsor: Greater Houston Retina Research

Brief Summary

This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.

Detailed Description

Uveal melanoma is the most common primary malignancy of the eye and is one of the few fatal diseases that are detected initially through an eye examination. For many years, clinical decision-making regarding which patient with uveal melanoma required treatment has been based solely on clinical features observed at the time of diagnosis. These features include: tumor size as measured by ultrasound, associated subretinal fluid, presence of orange lipofuscin pigment, lack of drusen, posterior location, and ciliary body involvement. All of these clinical features have been demonstrated to be associated with tumor growth which is associated with the eventual development of metastases. However, these clinical features are not adequately sensitive or specific enough to predict which patients will develop metastases.

More recently, researchers studying the genomics of uveal melanoma have focused on identifying genetic abnormalities present in tumor tissue in order to characterize these lesions more fully. Several landmark papers over the past 15 years have reported cytogenic and genomic abnormalities in uveal melanoma tumor tissue that are associated with a poorer prognosis. Although rare, there have been at least five cases in which patients undergoing biopsy of these lesions have developed extraocular spread of melanoma from the biopsy sites. With this new technique, the possible rate of extraocular spread should be lower, making the biopsy a safer technique than what is currently in practice.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Diagnosed with uveal melanoma
• Scheduled for enucleation surgery

Exclusion Criteria

• Patients under 21 years old
• Patients unable to undergo surgery
• Patients with known metastatic uveal melanoma or other cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with melanotic cells present at biopsy needle site	1 Year

Trial Locations

Locations (1)

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States