跳至主要内容
临床试验/NCT03721042
NCT03721042终止不适用

Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples

Nouvelle Clinique Bonnefon2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
68
试验地点
2
主要终点
positive predictive value and negative predictive value

研究概览

简要总结

The investigators don't know yet how the nose and the brain decode the smells. Scientific studies in neuroscience have shown that people who have tumors may have changes in the smell of secretions. Dogs are extremely efficient at detecting these changes, even before imaging studies. A review of the recent literature shows the different work done on the diagnosis of dogs on human pathologies, especially oncology. It is now known that the smell of exhaled gases is representative of the intestinal biotope and that a large number of pathologies are related to the type of microbial populations that inhabit the intestines.

Copying the olfactory organs could thus be of major interest for the early diagnosis of pathologies. More and more works are interested in the diagnostic power of electronic noses. From a technical point of view, these are nano-sensors that mimic the olfactory receptors from the breath gas of the subjects. They analyze the molecules present and compare them with a database to establish a diagnosis according to a probabilistic algorithm.

The use of exhaled air for the diagnosis of cancerous pathologies has already been the subject of scientific work. A classification using the SVM (support vector machine) method using data from 320 sensors made it possible to differentiate patients with lung cancer from controls in 98.8% of cases. The differential diagnosis of obstructive bronchopneumopathy was also very well done in this same study. Another study shows equally encouraging results, highlighting sensitivities and specificities above 80%.

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

入选标准

  • The patient must have signed the free and informed consent form or their guardian if applicable. If the state of health of the patient does not allow him to give and sign his consent, it will be sought from the person of trust
  • The patient must be an affiliate or beneficiary of a health insurance plan
  • The patient is at least 18 years old

排除标准

  • The patient participates or has participated within 3 months in another study that may have modified their intestinal biotope
  • The patient is in an exclusion period determined by a previous study
  • The patient is under the protection of justice
  • The patient or guardian or trusted person refuses to sign the consent
  • The patient does not read the French language fluently
  • The patient claims to be pregnant
  • The patient is breastfeeding

结局指标

主要结局

positive predictive value and negative predictive value

时间窗: 18 months

positive predictive value and negative predictive value of the electronic nose

次要结局

未报告次要终点

研究者

发起方
Nouvelle Clinique Bonnefon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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