Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia
研究概览
简要总结
This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female above 18 years of age;
- •Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes.
排除标准
- •Individuals whose pathology cannot be obtained or retrieved.
- •Inability to provide informed consent.
结局指标
主要结局
Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia
时间窗: 3 years
To correct for skin color effect and heterogeneity, the readings of the pigmented lesion will be normalized by the readings taken from the corresponding normal skin around the lesion.
次要结局
- To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;(3 years)
- To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure(3 years)
- To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions(3 years)
研究者
Yang Liu, PhD
Principal Investigator
University of Pittsburgh