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
研究组 & 干预措施
Nevisense
This will be a prospective investigator-initiated study to evaluate the accuracy of Nevisense for KC. First evaluation steps include dermatologist's clinical examination (visual inspection) and videodermoscopy. In those cases where the routine diagnostic procedures given above identify any suspicion of a KC, a Nevisense measurement is to be conducted after examination of inclusion and exclusion criteria. Thereafter, surgical excision and histopathologic examination follow.
All skin lesions with a suspicion of BCC, iSCC, BD or AK and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study. A maximum of three lesions per patient will be allowed for the study. The study aims to enrol 250 lesions in total.
干预措施: Nevisense (Device)
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