NCT01556503已完成不适用
Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sensitivity of confocal microscope to improve melanoma detection
研究概览
简要总结
The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 or older
- •Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study
- •Signed informed consent
排除标准
- •Age < 12 years
结局指标
主要结局
Sensitivity of confocal microscope to improve melanoma detection
时间窗: Up to 1 year
Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.
Specificity of the confocal microscope to improve melanoma detection
时间窗: Up to 1 year
Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis
次要结局
- Patterns seen on the confocal image(Up to 1 year)
研究者
研究点 (1)
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