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临床试验/NCT02851420
NCT02851420已完成不适用

Interest of Spectroscopy in the Diagnosis of Cancerous and Precancerous Lesions of the Upper Airways (UA): Pilot Study

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2016年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Reflectance spectrum of haemoglobin

研究概览

简要总结

The detection of suspect lesions is based on the clinical examination of the oral cavity and pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be difficult. On the one hand , it is an invasive procedure, and may engender complications, and on the other hand, certain modifications of the mucosa may be discrete, or not particularly specific or, on the contrary, disseminated or extremely widespread.

Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to restrict the use of biopsies to patients in whom it is really necessary 2) and to identify the area where the biopsy should be done in cases of multiple lesions. In this context, spectroscopy could be a promising alternative.

The investigator puts forward the hypothesis that cancerous and precancerous lesions of the mucosa of the upper airways and digestive tract present a characteristic spectrometric profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal wavelengths absorbed by haemoglobin.

This pilot study will make it possible to construct an algorithm that could be used to classify lesions of the upper airways and digestive tract as either seemingly benign or cancerous.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • patient - Patients consulting at the oto rhino laryngology department of Dijon for a functional symptom of the mouth, pharynx or larynx (pharyngeal discomfort, odynophagia, dysphagia, dysphonia, laryngeal dyspnoea) and in whom the clinical examination reveals a suspect lesion of the oral cavity, the pharynx or larynx and imposes an endoscopy procedure under general anaesthesia (unless it is a lesion of the tonsils or lingual tonsils)
  • Subjects who have provided consent
  • Subjects over 18 years old
  • volunteers:- Volunteers
  • Absence of risk factors cancerous oro-pharyngeal lesions, that is to say, non-smokers, alcohol consumption < 1 glass per day.
  • Absence of functional oto rhino laryngology symptoms (dyspnoea, dysphagia, dysphonia, pain)
  • Subjects who have provided consent
  • Subjects over 18 years old

排除标准

  • patient :- Patients without national health insurance cover
  • Pregnant or breast-feeding women
  • Biopsies not feasible
  • because of difficulty of exposure of the tumour
  • tumour not accessible to the biopsy forceps,
  • complications during the procedure making it impossible to do the biopsies (difficulties with ventilation)
  • Spectrometry not feasible
  • If exposure is difficult, tumour not accessible to the spectrometry probe (for example, a hypopharyngeal tumour in a patient with limited mouth opening)
  • In cases of anaesthesia complications, such as difficulties with ventilation
  • Lesions of the tonsils or lingual tonsil, suggesting lymphoma (exclusion of lymphoid tumours)
  • volunteers:- Persons without national health insurance cover
  • Pregnant or breast-feeding women
  • Presence of risk factors: alcohol-smoking
  • Presence of oto rhino laryngology functional symptoms

研究组 & 干预措施

control

Placebo Comparator

干预措施: spectroscopy (Other)

patient

Experimental

干预措施: spectroscopy (Other)

结局指标

主要结局

Reflectance spectrum of haemoglobin

时间窗: Day one

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 (2)

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