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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer, Non-small Cell
• Intervention / Treatment: Device: VOC analysis

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOC analysis; VOC analysis in exhaled air and sweat in patients treated by immunotherapy for lung cancer.	Device: VOC analysis; VOC analysis in exhaled air with e-noses and mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profiles of Volatil Organic Compound (VOC) in exhaled air	Comparison of variation of Volatil Organic Compound (VOC) profiles in exhaled air of patients before and during immunotherapy	1 day
Variation of Volatil Organic Compound (VOC) in exhaled air	Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)	change from baseline profiles at week 9, week 18 and week 27 post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profiles of Volatil Organic Compound (VOC) in sweat	Comparison of variation of Volatil Organic Compound (VOC) profiles in sweat of patients before and during immunotherapy	1 day
Variation of Volatil Organic Compound (VOC) in sweat	Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)	change from baseline profiles at week 9, week 18 and week 27 post-baseline
Volatil Organic Compound (VOC) profile and radiological response	Correlation between Volatil Organic Compound (VOC) profile before treatment and radiological response at 9, 18 and 27 weeks (defined by RECIST criteria)	change from baseline profiles at week 9, week 18 and week 27 post-baseline
Volatil Organic Compound (VOC) profile and drug toxicity	Correlation between variation of Volatil Organic Compound (VOC) profiles and apparition of drug toxicity at 9, 18 and 27 weeks	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	Comparison of performance of Volatil Organic Compound (VOC) from exhaled air versus Volatil Organic Compound (VOC) from sweat	1 day
Comparison of performance of mass spectrometry versus electronic noses	Comparison of performance of Volatil Organic Compound (VOC) from mass spectrometry versus Volatil Organic Compound (VOC) from electronic noses	1 day

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2018042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No