Lung Cancer, Non-small Cell
Conditions
Brief summary
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.
Interventions
DEVICEVOC analysis
VOC analysis in exhaled air with e-noses and mass spectrometry.
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profiles of Volatil Organic Compound (VOC) in exhaled air | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volatil Organic Compound (VOC) profile and radiological response | change from baseline profiles at week 9, week 18 and week 27 post-baseline | Correlation between Volatil Organic Compound (VOC) profile before treatment and radiological response at 9, 18 and 27 weeks (defined by RECIST criteria) |
| Volatil Organic Compound (VOC) profile and drug toxicity | change from baseline profiles at week 9, week 18 and week 27 post-baseline | Correlation between variation of Volatil Organic Compound (VOC) profiles and apparition of drug toxicity at 9, 18 and 27 weeks |
| Profiles of Volatil Organic Compound (VOC) in sweat | 1 day | Comparison of variation of Volatil Organic Compound (VOC) profiles in sweat of patients before and during immunotherapy |
| Comparison of performance of mass spectrometry versus electronic noses | 1 day | Comparison of performance of Volatil Organic Compound (VOC) from mass spectrometry versus Volatil Organic Compound (VOC) from electronic noses |
| Comparison of performance from Volatil Organic Compound (VOC) from exhaled air versus sweat | 1 day | Comparison of performance of Volatil Organic Compound (VOC) from exhaled air versus Volatil Organic Compound (VOC) from sweat |
| Variation of Volatil Organic Compound (VOC) in sweat | 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) |
Countries
France
Outcome results
None listed