Lung Cancer, Non-small CellOnco-VOCNCT03803137
Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
A study testing VOC analysis in people with Lung Cancer, Non-small Cell, run by Hopital Foch at 1 site in France.
Trial summary
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to Sep 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 non-small cell lung cancer
- Operable grade I or II
- No specific treatment before surgery (radiotherapy, chemotherapy or targeted therapy)
- Patient with healthcare insurance
- Non Inclusion Criteria:
Show all 12Show fewer
- Treatment with radiotherapy, chemotherapy, or neoadjuvant cancer targeted therapy before thoracic surgery
- Patient with oxygen therapy or invasive ventilation
- Patient unable to perform a slow vital capacity
- Dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance)
- Pregnant women
- Patient deprived of liberty by judicial or administrative decision
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Foch
Suresnes, 92150
Philippe Devillier, 33 1 46 25 27 91, p.devillier@hopital-foch.com
About this study
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.
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.
Read more
The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.
The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.
- 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 analysisOther
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 with thoracic surgery for carcinological resection Receives: Other: VOC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry)
Measured: change from baseline profiles at 2 month post-surgery
Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses
Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by the sensor deflection (by the electronic noses).
Measured: change from baseline profiles at 2 month post-surgery
Secondary outcomes (4)
Comparison of Volatil Organic Compound (VOC) profiles in sweat
Comparison of Volatil Organic Compound (VOC) profiles in sweat of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry).
Measured: 30 days before the surgery and 45 to 75 days after surgery
Variation of Volatil Organic Compound (VOC) and relapse rate
Correlation between the variation of Volatil Organic Compound (VOC) before-after surgery and relapse rate at 2 years
Measured: 30 days before the surgery, 45 to 75 days after surgery and 2 years
Correlation between Volatil Organic Compound (VOC) profiles and relapse rate
Correlation between the Volatil Organic Compound (VOC) profiles 2 months after the surgery and relapse rate at 2 years
Measured: 2 months and 2 years after surgery
Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue
Comparison of Volatil Organic Compound (VOC) profiles in exhaled air of patients and those released ex-vivo by the tumoral lung tissue. The VOC will be identified by their molecular mass (by the mass spectrometry).
Measured: 30 days before the surgery, day of surgery and 45 to 75 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start20 Sep 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
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
- 50 participants (estimated)
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
- NCT03803137
- Sponsor's protocol ID
- 2017081
- Acronym
- Onco-VOC
- Status last verified
- Dec 2020
- First submitted
- 5 Oct 2018
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
- ClinicalTrials.gov ID
- NCT03803137
- Acronym / sponsor ID
- Onco-VOC / 2017081
- Conditions
- Lung Cancer, Non-small Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Jan 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.
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.
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.
The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.
The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.
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 | Other: VOC analysisVOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection |
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 non-small cell lung cancer
- Operable grade I or II
- No specific treatment before surgery (radiotherapy, chemotherapy or targeted therapy)
- 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 | Other | VOC analysis |
Primary outcome
Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
Time frame: change from baseline profiles at 2 month post-surgery
Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry)
Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses
Time frame: change from baseline profiles at 2 month post-surgery
Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by the sensor deflection (by the electronic noses).
4 secondary outcomes
Comparison of Volatil Organic Compound (VOC) profiles in sweat
Time frame: 30 days before the surgery and 45 to 75 days after surgery
Variation of Volatil Organic Compound (VOC) and relapse rate
Time frame: 30 days before the surgery, 45 to 75 days after surgery and 2 years
Correlation between Volatil Organic Compound (VOC) profiles and relapse rate
Time frame: 2 months and 2 years after surgery
Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue
Time frame: 30 days before the surgery, day of surgery and 45 to 75 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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: status not confirmed, as of the sponsor's last update on 19 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Hullier-Ammar (+33 1 46 25 11 75, drci-promotion@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry (time frame: change from baseline profiles at 2 month post-surgery). 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 19 Dec 2020.