New Biopsy Technique for Uveal Melanoma

Uveal Melanoma Clinical Trial

Official title:

New Biopsy Technique for Uveal Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924923
• Other study ID #: NBT-01
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: March 25, 2015
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Greater Houston Retina Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Locations

Country	Name	City	State
United States	Retina Consultants of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Greater Houston Retina Research	The Methodist Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (11)

Caminal JM, Sanz S, Carreras M, Català I, Arruga J, Roca G. Epibulbar seeding at the site of a transvitreal fine-needle aspiration biopsy. Arch Ophthalmol. 2006 Apr;124(4):587-9. — View Citation

Engzell U, Esposti PL, Rubio C, Sigurdson A, Zajicek J. Investigation on tumour spread in connection with aspiration biopsy. Acta Radiol Ther Phys Biol. 1971 Aug;10(4):385-98. — View Citation

Glasgow BJ, Brown HH, Zargoza AM, Foos RY. Quantitation of tumor seeding from fine needle aspiration of ocular melanomas. Am J Ophthalmol. 1988 May 15;105(5):538-46. — View Citation

Jakobiec FA, Coleman DJ, Chattock A, Smith M. Ultrasonically guided needle biopsy and cytologic diagnosis of solid intraocular tumors. Ophthalmology. 1979 Sep;86(9):1662-81. — View Citation

Karcioglu ZA, Gordon RA, Karcioglu GL. Tumor seeding in ocular fine needle aspiration biopsy. Ophthalmology. 1985 Dec;92(12):1763-7. — View Citation

Schefler AC, Gologorsky D, Marr BP, Shields CL, Zeolite I, Abramson DH. Extraocular extension of uveal melanoma after fine-needle aspiration, vitrectomy, and open biopsy. JAMA Ophthalmol. 2013 Sep;131(9):1220-4. doi: 10.1001/jamaophthalmol.2013.2506. — View Citation

Schyberg E. Fine needle biopsy of orbital tumours [proceedings]. Acta Ophthalmol Suppl. 1975;(125):11. — View Citation

Shields JA, Shields CL, Ehya H, Eagle RC Jr, De Potter P. Fine-needle aspiration biopsy of suspected intraocular tumors. The 1992 Urwick Lecture. Ophthalmology. 1993 Nov;100(11):1677-84. — View Citation

SNELL AC Jr. Heterotransplantation of tumors into various regions of the guinea-pig eye. Am J Ophthalmol. 1951 May;34(5 1):733-8. — View Citation

The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10. Am J Ophthalmol. 1998 Jun;125(6):779-96. — View Citation

The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11. Am J Ophthalmol. 1998 Sep;126(3):362-72. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with melanotic cells present at biopsy needle site		1 Year	No