New Biopsy Technique for Uveal Melanoma

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.

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

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