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

Lung Cancer, Non-small Cell Clinical Trial

— Immuno-VOC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03988192
• Other study ID #: 2018042
• Status: Terminated
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: May 26, 2021

Study information

• Verified date: January 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-small Cell
• Lung Neoplasms

Intervention

Device:
• VOC analysis
VOC analysis in exhaled air with e-noses and mass spectrometry.

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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