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临床试验/NCT01924923
NCT01924923已完成不适用

New Biopsy Technique for Uveal Melanoma

Greater Houston Retina Research1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Number of subjects with melanotic cells present at biopsy needle site

研究概览

简要总结

This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.

详细描述

Uveal melanoma is the most common primary malignancy of the eye and is one of the few fatal diseases that are detected initially through an eye examination. For many years, clinical decision-making regarding which patient with uveal melanoma required treatment has been based solely on clinical features observed at the time of diagnosis. These features include: tumor size as measured by ultrasound, associated subretinal fluid, presence of orange lipofuscin pigment, lack of drusen, posterior location, and ciliary body involvement. All of these clinical features have been demonstrated to be associated with tumor growth which is associated with the eventual development of metastases. However, these clinical features are not adequately sensitive or specific enough to predict which patients will develop metastases.

More recently, researchers studying the genomics of uveal melanoma have focused on identifying genetic abnormalities present in tumor tissue in order to characterize these lesions more fully. Several landmark papers over the past 15 years have reported cytogenic and genomic abnormalities in uveal melanoma tumor tissue that are associated with a poorer prognosis. Although rare, there have been at least five cases in which patients undergoing biopsy of these lesions have developed extraocular spread of melanoma from the biopsy sites. With this new technique, the possible rate of extraocular spread should be lower, making the biopsy a safer technique than what is currently in practice.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with uveal melanoma
  • Scheduled for enucleation surgery

排除标准

  • Patients under 21 years old
  • Patients unable to undergo surgery
  • Patients with known metastatic uveal melanoma or other cancer.

结局指标

主要结局

Number of subjects with melanotic cells present at biopsy needle site

时间窗: 1 Year

次要结局

未报告次要终点

研究者

发起方
Greater Houston Retina Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy C Schefler, MD

Director of Ophthalmic Oncology

Greater Houston Retina Research

研究点 (1)

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