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Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)

18 Years
Open (Enrolling)
Intraocular Melanoma

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Trial Information

Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)



- To establish the feasibility of using fine needle aspiration (FNA) and FISH to
determine tumor genotype in patients with primary uveal melanoma.


- To characterize ophthalmic complication rate of FNA for FISH analysis in patients
undergoing plaque radiotherapy.

- To estimate disease-free survival in patients with and without tumor monosomy 3 and/or
8q amplification.

- To explore the relationship between tumor monosomy 3 and 8q amplification and plasma
levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin,
beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7,
tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin).

- To explore the psychological impact of prognostication in uveal melanoma.

OUTLINE: Patients undergo plaque radiotherapy, enucleation, or tumor resection based upon
standard of care guidelines.

Trans-scleral fine needle aspiration (FNA) is performed at the time of plaque radiotherapy
and ex vivo FNA is performed on enucleation and tumor resection specimens. Tissue samples
are analyzed by fluorescence in situ hybridization (FISH). Blood samples are also collected
for further analysis.

After completion of study therapy, patients are followed up periodically.

Inclusion Criteria

Inclusion Criteria

- Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or

- Patients must have had a hepatic ultrasound and/or other suitable imaging studies to
eliminate metastatic disease

- Patients must not have received any local or systemic therapy for uveal melanoma

- All patients must be informed of the investigational nature of this study and must
provide written informed consent in accordance with institutional and federal
guidelines. A copy of the informed consent document signed by the patient must be
given to the patient

- Patients must have the following pretreatment laboratory findings:

- Bilirubin (total)
- Alkaline phosphatase
Exclusion Criteria

- Patients with metastasis

- Patients under the age of 18

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes

Outcome Description:

DFS will be measured from the date of initial treatment to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Arun D. Singh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

May 2013

Related Keywords:

  • Intraocular Melanoma
  • ciliary body and choroid melanoma, small size
  • iris melanoma
  • intraocular melanoma
  • ciliary body and choroid melanoma, medium/large size
  • Melanoma
  • Uveal Neoplasms



Cleveland Clinic Cole Eye InstituteCleveland, Ohio  44195