Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response

Not Applicable

Terminated

• Conditions: Lung Cancer, Non-small Cell
• Interventions: Device: VOC analysis

• Registration Number: NCT03988192
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VOC analysis	VOC analysis	VOC analysis in exhaled air and sweat in patients treated by immunotherapy for lung cancer.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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
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)
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

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France