Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- SciBase AB
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Nevisense Sensitivity and Specificity
研究概览
简要总结
This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.
All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)
排除标准
- •Metastases of recurrent lesions
- •Lesion located on acral skin, e.g. sole or palm
- •Lesion located on areas of scars, crusts, psoriasis or similar skin conditions
- •Lesion on hair-covered areas, e.g. scalp, beards, moustaches
- •Lesion located on genitalia
- •Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized
- •Lesion located on mucosal surfaces
- •Lesion with foreign matter, e.g. tattoo or splinter
- •Lesion and / or reference located on acute sunburn
- •Skin surface not measurable, e.g. lesion on a stalk
- •Skin surface not accessible, e.g. inside ears, under nails
结局指标
主要结局
Nevisense Sensitivity and Specificity
时间窗: 1 year
This study has two primary endpoints: 1. Sensitivity ≥ 0.90 2. Sensitivity + Specificity \> 1.0 Sensitivity is the proportion of correctly identified cases of KC. Specificity is the proportion of correctly identified cases of non-KC
次要结局
未报告次要终点