Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Resolution of normal and cancerous tissue
研究概览
简要总结
The trial is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of ex-vivo tissue analysis using differential mobility spectrometry (DMS) of tissue smoke generated by the use of an electrosurgical instrument.
Patients recruited in the trial receive standard-of-care basal cell carcinoma tumor excision surgery.
详细描述
Basal cell carcinoma (BCC) is the most common cancer in Caucasians and the average risk of developing BCC is approximately 30% (1,2). In Finland, BCC is the most common cancer and the incidence of BCC is approximately 49/100 000 in men and 45/100 000 in women (3).
There are several types of BCC (4) of which superficial type can be managed with non-operative treatment. All the other types of BCC (micronodular, nodular, infiltrative) require operative treatment which means surgical removal of the tumor with a few millimeters healthy skin margin (5). The aim of the operative treatment is to remove the tumor entirely so that the healthy skin margins are as sparing as possible and that the functional and cosmetic outcomes are as satisfactory as possible. Margin positiveness leads to one or more reoperations which increase the risk of surgical complications.
Differential mobility spectrometry (DMS) based application called automatic tissue analysis (ATAS) can be utilized to identify tumor cells from healthy tissue. Tissue identification is done by analyzing tissue smoke that is generated by the use of an electrosurgical instrument called diathermy (6,7).
The objective of the trial is to test whether it is possible to identify BCC from normal skin by using ATAS. A 4mm punch biopsy of BCC tumor and a control biopsy of healthy skin will be collected from 30 - 40 patients undergoing BCC tumor excision. The biopsies will be examined in the research laboratory with ATAS to test tissue recognition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Punch biopsy diagnosed basal cell carcinoma.
- •Tumor diameter of 1,5 cm or larger.
- •Operable patient that is willing to participate in the trial.
排除标准
- •Tumor diameter of less than 1,5 cm.
- •Patient that is unsuitable to take part in the trial, for example, has a tendency to develop keloids.
- •Patient that is unwilling to take part in the trial.
- •Patient that is not able to understand given information concerning the trial or to give consent to take part in the trial.
结局指标
主要结局
Resolution of normal and cancerous tissue
时间窗: Through study completion, an average of 1 year
The ATAS device records a molecular spectrum of the surgical smoke generated when the collected tissue samples are processed with an electrosurgical instrument in the research laboratory. The primary outcome of the study is to test the ability of the device to correctly distinguish cancerous tissue from normal tissue based on predicted differences in the spectrum.
次要结局
- Differentiation of basal cell carcinoma histopathological sub-types(Through study completion, an average of 1 year)
- The influence of basal cell carcinoma tumor thickness and infiltration depth on the resolution(Through study completion, an average of 1 year)