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

NCT ID: NCT03988192

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2021-05-26

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.

Conditions

Lung Cancer, Non-small Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VOC analysis

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

Group Type: EXPERIMENTAL

VOC analysis

Intervention Type: DEVICE

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

Interventions

VOC analysis

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

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Devillier

Role: PRINCIPAL_INVESTIGATOR

Pneumology department

Locations

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

2018042

Identifier Type: -

Identifier Source: org_study_id