Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Profiles of Volatil Organic Compound (VOC) in exhaled air
研究概览
简要总结
The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.
Immunotherapy is a new therapeutic approach used in non small cell lung cancer in a late stage.
VOC analysis could allow to identify biomarkers of early response to immunotherapy. The study of VOC could help in the optimisation of immunotherapy prescription in lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •patient aged > 18 years old
- •patient with metastatic non-small cell lung cancer with marketing authorisation criteria for immunotherapy
- •preserved overall condition (Performans Status 1)
- •signed informed consent
- •patient with healthcare insurance
- •Non Inclusion Criteria:
- •patient with oxygen therapy or invasive ventilation
- •patient unable to perform a slow vital capacity
- •systemic corticosteroid therapy more than 10 mg per day of prednisone equivalent
- •previous treatment with immunotherapy
- •dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance)
- •Patient deprived of liberty by judicial or administrative decision
排除标准
- 未提供
结局指标
主要结局
Profiles of Volatil Organic Compound (VOC) in exhaled air
时间窗: 1 day
Comparison of variation of Volatil Organic Compound (VOC) profiles in exhaled air of patients before and during immunotherapy
Variation of Volatil Organic Compound (VOC) in exhaled air
时间窗: change from baseline profiles at week 9, week 18 and week 27 post-baseline
Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)
次要结局
- Volatil Organic Compound (VOC) profile and radiological response(change from baseline profiles at week 9, week 18 and week 27 post-baseline)
- Comparison of performance from Volatil Organic Compound (VOC) from exhaled air versus sweat(1 day)
- Volatil Organic Compound (VOC) profile and drug toxicity(change from baseline profiles at week 9, week 18 and week 27 post-baseline)
- Profiles of Volatil Organic Compound (VOC) in sweat(1 day)
- Variation of Volatil Organic Compound (VOC) in sweat(change from baseline profiles at week 9, week 18 and week 27 post-baseline)
- Comparison of performance of mass spectrometry versus electronic noses(1 day)