New Biopsy Technique for Uveal Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Greater Houston Retina Research
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
Amy C Schefler, MD, Greater Houston Retina Research
ClinicalTrials.gov Identifier:
NCT01924923
First received: August 13, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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


Condition
Uveal Melanoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: New Biopsy Technique for Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by Greater Houston Retina Research:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 15
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)
Groups/Cohorts
Uveal Melanoma
Scheduled for enucleation surgery

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924923

Locations
United States, Texas
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Contact: Cassie Cone    713-524-3434    ccone@houstonretina.com   
Principal Investigator: Amy C Schefler, MD         
Sub-Investigator: Patricia Chevez-Barrios, MD         
Sponsors and Collaborators
Greater Houston Retina Research
The Methodist Hospital System
Investigators
Principal Investigator: Amy C. Schefler, MD Retina Consultants of Houston
  More Information

Publications:

Responsible Party: Amy C Schefler, MD, Director of Ophthalmic Oncology, Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01924923     History of Changes
Other Study ID Numbers: NBT-01
Study First Received: August 13, 2013
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Greater Houston Retina Research:
uveal melanoma
biopsy
enucleation
ocular cancer

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

ClinicalTrials.gov processed this record on October 21, 2014