Clinical trial NCT03988192: Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response
Official title: Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer, Non-small Cell
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Profiles of Volatil Organic Compound (VOC) in exhaled air
timeFrame: 1 day
measure: Variation of Volatil Organic Compound (VOC) in exhaled air
timeFrame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
Secondary outcomes:
measure: Profiles of Volatil Organic Compound (VOC) in sweat
timeFrame: 1 day
measure: Variation of Volatil Organic Compound (VOC) in sweat
timeFrame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
measure: Volatil Organic Compound (VOC) profile and radiological response
timeFrame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
measure: Volatil Organic Compound (VOC) profile and drug toxicity
timeFrame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
measure: Comparison of performance from Volatil Organic Compound (VOC) from exhaled air versus sweat
timeFrame: 1 day
measure: Comparison of performance of mass spectrometry versus electronic noses
timeFrame: 1 day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Pneumology department
name: Philippe Devillier
role: PRINCIPAL_INVESTIGATOR
References: