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

NCT03988192 | Terminated

• 1 other identifier: 2018042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Profiles of Volatil Organic Compound (VOC) in sweat

  1 day

• Variation of Volatil Organic Compound (VOC) in sweat

  change from baseline profiles at week 9, week 18 and week 27 post-baseline

• Volatil Organic Compound (VOC) profile and radiological response

  change from baseline profiles at week 9, week 18 and week 27 post-baseline

• Volatil Organic Compound (VOC) profile and drug toxicity

  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

  1 day

Study Arms (1)

VOC analysis

EXPERIMENTAL

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

Device: VOC analysis

Interventions

VOC analysis DEVICE

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

VOC analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philippe Devillier

  Pneumology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: June 17, 2019
• Study Start: August 28, 2018
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

FR (1)