New Biopsy Technique for Uveal Melanoma
This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||New Biopsy Technique for Uveal Melanoma|
- Number of subjects with melanotic cells present at biopsy needle site [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
The eye will be enucleated and histopathologic sections of the sclera will be examined for extra scleral extension of cells. After the tissues are examined, they will be stored in the ocular histopathology lab for 10 years.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Scheduled for enucleation surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01924923
|United States, Texas|
|Retina Consultants of Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Cassie Cone 713-524-3434 firstname.lastname@example.org|
|Principal Investigator: Amy C Schefler, MD|
|Sub-Investigator: Patricia Chevez-Barrios, MD|
|Principal Investigator:||Amy C. Schefler, MD||Retina Consultants of Houston|