New Biopsy Technique for Uveal Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01924923
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : March 26, 2015
The Methodist Hospital System
Information provided by (Responsible Party):
Amy C Schefler, MD, 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.

Condition or disease
Uveal Melanoma

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
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: New Biopsy Technique for Uveal Melanoma
Study Start Date : June 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Uveal Melanoma
Scheduled for enucleation surgery

Primary Outcome Measures :
  1. Number of subjects with melanotic cells present at biopsy needle site [ Time Frame: 1 Year ]

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.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 21, diagnosed with uveal melanoma and scheduled to undergo enucleation surgery. No known metastatis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01924923

United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Greater Houston Retina Research
The Methodist Hospital System
Principal Investigator: Amy C. Schefler, MD Retina Consultants Houston


Responsible Party: Amy C Schefler, MD, Director of Ophthalmic Oncology, Greater Houston Retina Research Identifier: NCT01924923     History of Changes
Other Study ID Numbers: NBT-01
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Amy C Schefler, MD, Greater Houston Retina Research:
uveal melanoma
ocular cancer

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases