Brief Title
New Biopsy Technique for Uveal Melanoma
Official Title
New Biopsy Technique for Uveal Melanoma
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 Type
Observational
Primary Outcome
Number of subjects with melanotic cells present at biopsy needle site
Condition
Uveal Melanoma
Study Arms / Comparison Groups
Uveal Melanoma
Description: Scheduled for enucleation surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1
Start Date
June 2013
Completion Date
March 2015
Primary Completion Date
March 2015
Eligibility Criteria
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.
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amy C. Schefler, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01924923
Organization ID
NBT-01
Responsible Party
Principal Investigator
Study Sponsor
Greater Houston Retina Research
Collaborators
The Methodist Hospital Research Institute
Study Sponsor
Amy C. Schefler, MD, Principal Investigator, Retina Consultants Houston
Verification Date
March 2015