Clinical trial NCT01924923: New Biopsy Technique for Uveal Melanoma
Official title: New Biopsy Technique for Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveal Melanoma
Keywords: uveal melanoma
biopsy
enucleation
ocular cancer
Lead sponsor: Greater Houston Retina Research
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2013-08-19
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 21, diagnosed with uveal melanoma and scheduled to undergo enucleation surgery. No known metastatis.

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.

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.

Primary outcomes:
measure: Number of subjects with melanotic cells present at biopsy needle site
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Retina Consultants Houston
name: Amy C. Schefler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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