Clinical trial · Observational
Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye
Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)
NCT00952939CI-TRIAL-00016749completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fine-needle aspiration | Procedure | — | UNRESOLVED |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes
- timeFrame
- 2 years
- 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.
Secondary outcomes (3)
- 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
- description
- To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
- measure
- The rate that sufficient tissue can be obtained by FNA.
- timeFrame
- 2 yrs
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.