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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE5608 | Other Identifier | Case Comprehensive Cancer Center | |
| CASE 5608-CC666 | Other Identifier | Cancer Center IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorescence in situ hybridization | Genetic | At time of surgery | ||
| laboratory biomarker analysis | Other | At time of surgery | ||
| fine-needle aspiration | Procedure | At time of surgery | ||
| therapeutic conventional surgery | Procedure | At time of surgery | ||
| Questionnaires | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The rate that sufficient tissue can be obtained by FNA. |
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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:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Arun D. Singh, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
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|
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 |
| 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 |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D017404 | In Situ Hybridization, Fluorescence |
| D044963 | Biopsy, Fine-Needle |
| D011795 | Surveys and Questionnaires |
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
| ID | Term |
|---|---|
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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