Lung Cancer, Non-small CellImmuno-VOCNCT03988192
Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response
A study testing VOC analysis in people with Lung Cancer, Non-small Cell, run by Hopital Foch at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell
- What is being tested?
- VOC analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- VOC analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOC analysisDevice
VOC analysis in exhaled air with e-noses and mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| VOC analysis | Experimental | VOC analysis in exhaled air and sweat in patients treated by immunotherapy for lung cancer. Receives: Device: VOC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Comparison of variation of Volatil Organic Compound (VOC) profiles in sweat of patients before and during immunotherapy
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start28 Aug 2018
- Primary completion26 May 2021
- Study completion26 May 2021
Why it stopped: Evolution of the treatment procedures so that their is no more benefits for patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Devillier, Principal investigator, Pneumology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988192
- Sponsor's protocol ID
- 2018042
- Acronym
- Immuno-VOC
- Status last verified
- Jan 2022
- First submitted
- 5 Oct 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03988192
- Acronym / sponsor ID
- Immuno-VOC / 2018042
- Conditions
- Lung Cancer, Non-small Cell
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evolution of the treatment procedures so that their is no more benefits for patients
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VOC analysis | Experimental | Device: VOC analysisVOC analysis in exhaled air and sweat in patients treated by immunotherapy for lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOC analysisVOC analysis in exhaled air with e-noses and mass spectrometry. | Device | VOC analysis |
Primary outcome
Profiles of Volatil Organic Compound (VOC) in exhaled air
Time frame: 1 day
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
Time frame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)
6 secondary outcomes
Profiles of Volatil Organic Compound (VOC) in sweat
Time frame: 1 day
Variation of Volatil Organic Compound (VOC) in sweat
Time frame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
Volatil Organic Compound (VOC) profile and radiological response
Time frame: change from baseline profiles at week 9, week 18 and week 27 post-baseline
Volatil Organic Compound (VOC) profile and drug toxicity
Time frame: 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
Time frame: 1 day
Comparison of performance of mass spectrometry versus electronic noses
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Evolution of the treatment procedures so that their is no more benefits for patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Devillier principal investigator
Pneumology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOC analysis in people with Lung Cancer, Non-small Cell, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Evolution of the treatment procedures so that their is no more benefits for patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiles of Volatil Organic Compound (VOC) in exhaled air (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.