Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye

Intraocular Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952939
• Other study ID #: CASE5608
• Secondary ID: P30CA043703CASE5
• Status: Completed
• Phase: N/A
• First received: August 5, 2009
• Last updated: January 28, 2015
• Start date: March 2009
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Uveal Neoplasms

Intervention

Genetic:
• fluorescence in situ hybridization
At time of surgery

Other:
• laboratory biomarker analysis
At time of surgery

Procedure:
• fine-needle aspiration
At time of surgery
• therapeutic conventional surgery
At time of surgery

Other:
• Questionnaires
The MINI (a structured psychiatric interview) will be administered to all patients that had a pre or post-operative HADS score for suggestive or probable depression or anxiety. A semi-structured interview would be administered to those patients who had some or full decision regret pre-operatively. After completion of the interview, the MINI, a structured psychiatric interview, will be administered.

Locations

Country	Name	City	State
United States	Cleveland Clinic Cole Eye Institute	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes	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.	2 years	No
Secondary	Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.	To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.	2 years	No
Secondary	The rate that sufficient tissue can be obtained by FNA.	Determine if sufficient material for FISH analysis can be obtained by transscleral FNA, a diagnostic procedure performed for a variety of clinical indications in patients with eye abnormalities.	2 yrs	No
Secondary	distribution of particular markers at specific timepoints	Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.	at baseline, multiple time points up to 2 years	No