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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)

Primary Purpose

Lung Cancer, Non-small Cell

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VOC analysis
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer, Non-small Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VOC analysis

Arm Description

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

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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
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)
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)
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
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
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

Full Information

First Posted
October 5, 2018
Last Updated
January 12, 2022
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT03988192
Brief Title
Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Evolution of the treatment procedures so that their is no more benefits for patients
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small Cell

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VOC analysis
Arm Type
Experimental
Arm Description
VOC analysis in exhaled air and sweat in patients treated by immunotherapy for lung cancer.
Intervention Type
Device
Intervention Name(s)
VOC analysis
Intervention Description
VOC analysis in exhaled air with e-noses and mass spectrometry.
Primary Outcome Measure Information:
Title
Profiles of Volatil Organic Compound (VOC) in exhaled air
Description
Comparison of variation of Volatil Organic Compound (VOC) profiles in exhaled air of patients before and during immunotherapy
Time Frame
1 day
Title
Variation of Volatil Organic Compound (VOC) in exhaled air
Description
Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)
Time Frame
change from baseline profiles at week 9, week 18 and week 27 post-baseline
Secondary Outcome Measure Information:
Title
Profiles of Volatil Organic Compound (VOC) in sweat
Description
Comparison of variation of Volatil Organic Compound (VOC) profiles in sweat of patients before and during immunotherapy
Time Frame
1 day
Title
Variation of Volatil Organic Compound (VOC) in sweat
Description
Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)
Time Frame
change from baseline profiles at week 9, week 18 and week 27 post-baseline
Title
Volatil Organic Compound (VOC) profile and radiological response
Description
Correlation between Volatil Organic Compound (VOC) profile before treatment and radiological response at 9, 18 and 27 weeks (defined by RECIST criteria)
Time Frame
change from baseline profiles at week 9, week 18 and week 27 post-baseline
Title
Volatil Organic Compound (VOC) profile and drug toxicity
Description
Correlation between variation of Volatil Organic Compound (VOC) profiles and apparition of drug toxicity at 9, 18 and 27 weeks
Time Frame
change from baseline profiles at week 9, week 18 and week 27 post-baseline
Title
Comparison of performance from Volatil Organic Compound (VOC) from exhaled air versus sweat
Description
Comparison of performance of Volatil Organic Compound (VOC) from exhaled air versus Volatil Organic Compound (VOC) from sweat
Time Frame
1 day
Title
Comparison of performance of mass spectrometry versus electronic noses
Description
Comparison of performance of Volatil Organic Compound (VOC) from mass spectrometry versus Volatil Organic Compound (VOC) from electronic noses
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier
Organizational Affiliation
Pneumology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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