Clinical trial NCT00952939: Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye
Official title: Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Melanoma
Keywords: ciliary body and choroid melanoma, small size
iris melanoma
intraocular melanoma
ciliary body and choroid melanoma, medium/large size
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.

Detailed description: OBJECTIVES:

Primary

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

Secondary

* 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.

Eligibility criteria: Inclusion Criteria

* Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids
* 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) \</= 1.5 ml/dl
  * AST \</= 2 x normal
  * ALT \</= 2 x normal
  * Alkaline phosphatase \</= 2 x normal

Exclusion Criteria

* Patients with metastasis
* Patients under the age of 18

Primary outcomes:
measure: Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
timeFrame: 2 years
measure: The rate that sufficient tissue can be obtained by FNA.
timeFrame: 2 yrs
measure: distribution of particular markers at specific timepoints
timeFrame: at baseline, multiple time points up to 2 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Cole Eye Institute
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Arun D. Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: