跳至主要内容
临床试验/NCT05104619
NCT05104619招募中不适用

Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
14
试验地点
1
主要终点
Tumor cells detection in tongue tumor with SpiderMass technique

研究概览

简要总结

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age : 18 years and older
  • squamous cell carcinoma of the tongue
  • surgical resection as first-line treatment
  • tumor classification T1 to T4.

排除标准

  • metastatic disease
  • neoadjuvant therapies

结局指标

主要结局

Tumor cells detection in tongue tumor with SpiderMass technique

时间窗: 1 year

Tumor cells detection in tongue tumor with SpiderMass technique

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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