NCT03109327已完成不适用
Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Utility of the MDS in determining urgent or non-urgent excision of moles.
研究概览
简要总结
The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).
详细描述
The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lesion has one or more of the ABCDE features and is recommended for excision.
- •Lesion has at least 1 cm of skin around it that is accessible to the MDS.
- •Patient is at least 18 years old.
- •Patient is capable of giving written informed consent.
- •Lesion is scheduled for primary excision.
排除标准
- •Lesion is less than one centimetre from the eyes.
- •Lesion is on the palms of the hands or soles of the feet.
- •Lesion is mucosal.
- •Lesion is ulcerated.
- •Patient is pregnant.
- •Low patient study procedure compliance.
- •Patient who is mentally or physically unable to comply with all aspects of the study.
- •Patient is undergoing chemotherapy.
- •Patient has known sensitivity to fluorescent dyes.
- •Ink marking on or adjacent to lesion.
- •Lesions larger than 20mm or too large to allow imaging.
结局指标
主要结局
Utility of the MDS in determining urgent or non-urgent excision of moles.
时间窗: 1 day
The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation.
次要结局
- Does the MDS have an additive value to clinical evaluation of moles.(1 day)
研究者
研究点 (1)
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