Lung CancerNCT06288646
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer
An observational study of Lung Cancer and Non Small Cell Lung Cancer, run by Breathe BioMedical Inc at 1 site in Canada.
Trial summary
The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 24 Apr 2023to 15 May 2024
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants in all cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria. This study will enroll 30 patients from 3 different cohorts (confirmed NSCLS, stable pulmonary nodules, screened and negative controls). Additionally, a second breath sample may be taken from the 30 patients with lung cancer, totalling up to 120 breath samples.
Who may be able to join
- Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.
Who cannot join
- Patients are not eligible if they are currently receiving treatment for lung cancer.
- Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment.
- Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). We ask participants to refrain from:
- Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling;
- Consume alcohol (including mouthwash) at least 8 hours before breath sampling.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.
Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.
Read the detailed description
Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed Lung Cancer | To be eligible for the lung cancer group: * Aged 50 and over; * Current or former smoker with smoking history ≥ 20 pack-years; * Capacity to give informed consent; * Non-metastatic non-small cell lung cancer, that has not been treated * No history of active cancer in the past 5 years (exceptions include: Ductal carcinoma in situ (DCIS), cervical intraepithelial neoplasia (CIN), non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6); * Able to provide a breath sample. To be eligible for a second breath sample: * Same as above, in addition to, and with the exception of criterion 4: * Non-metastatic non-small cell lung cancer, which has undergone surgical resection; * 6 months since completion of surgery, radiation, and chemotherapy on primary NSCLC; * CT scan at least 6 months after surgical resection, confirming the absence of lung cancer. | |
| Control | For a participant to be eligible in the study control group: * Aged 50 and over; * Current or former smoker with smoking history ≥ 20 pack-years; * Capacity to give informed consent; * No history of active lung cancer; * No pulmonary nodule(s); * No active cancer in the last 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason ≤ 6 prostate cancer will be exceptions); * Ability to provide a breath sample. | |
| Stable pulmonary nodule | For a participant to be eligible for admission to the stable lung nodules group: * Aged 50 and over; * Current or former smoker with smoking history ≥ 20 pack-years; * Capacity to give informed consent; * No history of active lung cancer or other active cancer in the past 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6 or lower will be exceptions); * Presence of one or more stable lung nodules (as determined by the principal investigator); * Ability to provide a breath sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls
Using infrared cavity-ringdown spectroscopy, breath spectra of volatile organic compounds (VOCs) will be measured. Breath spectra will be statistically analyzed to identify features specific to each of the respective cohorts. These features will be used to train mathematical and statistical models to differentiate and categorize the samples within the three cohorts.
Measured: 2 years
Secondary outcomes (1)
Differences in breath spectra of patients with lung cancer before and after treatment
Using infrared cavity ring-down spectrometry, breath samples will be taken from individual patients before and after surgical resection of the tumour. The objective is to identify and measure intra-patient differences in respiratory profiles before and after treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start24 Apr 2023
- Primary completion16 Apr 2024
- Study completion15 May 2024
Why it stopped: Change in sponsor's business strategy (disease focus changed to breast cancer)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breathe BioMedical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitalite Health Network
- Responsible party
- Sponsor
- Investigators
- Nada Hammami, Study director, Vitalite Health NetworkMarcel Mallet, MD, Principal investigator, Vitalite Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288646
- Sponsor's protocol ID
- ROMEO 101712
- Status last verified
- May 2024
- First submitted
- 15 Nov 2023
- Last updated
- 31 May 2024
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT06288646
- Acronym / sponsor ID
- ROMEO 101712
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in sponsor's business strategy (disease focus changed to breast cancer)
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Breathe BioMedical IncIndustry (pharma, biotech, devices)
- Collaborators
- Vitalite Health Network
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 1 Mar 2024 (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 goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.
Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.
Detailed description
Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Confirmed Lung Cancer | – | –To be eligible for the lung cancer group: * Aged 50 and over; * Current or former smoker with smoking history ≥ 20 pack-years; * Capacity to give informed consent; * Non-metastatic non-small cell lung cancer, that has not been treated * No history of active cancer in the past 5 years (exceptions include: Ductal carcinoma in situ (DCIS), cervical intraepithelial neoplasia (CIN), non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6); * Able to provide a breath sample. To be eligible for a second breath sample: * Same as above, in addition to, and with the exception of criterion 4: * Non-metastatic non-small cell lung cancer, which has undergone surgical resection; * 6 months since completion of surgery, radiation, and chemotherapy on primary NSCLC; * CT scan at least 6 months after surgical resection, confirming the absence of lung cancer. |
| Control | – | –For a participant to be eligible in the study control group: * Aged 50 and over; * Current or former smoker with smoking history ≥ 20 pack-years; * Capacity to give informed consent; * No history of active lung cancer; * No pulmonary nodule(s); * No active cancer in the last 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason ≤ 6 prostate cancer will be exceptions); * Ability to provide a breath sample. |
| Stable pulmonary nodule | – | –For a participant to be eligible for admission to the stable lung nodules group: * Aged 50 and over; * Current or former smoker with smoking history ≥ 20 pack-years; * Capacity to give informed consent; * No history of active lung cancer or other active cancer in the past 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6 or lower will be exceptions); * Presence of one or more stable lung nodules (as determined by the principal investigator); * Ability to provide a breath sample. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants in all cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria. This study will enroll 30 patients from 3 different cohorts (confirmed NSCLS, stable pulmonary nodules, screened and negative controls). Additionally, a second breath sample may be taken from the 30 patients with lung cancer, totalling up to 120 breath samples.
Key inclusion criteria (1 listed)
- Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.
Key exclusion criteria (5 listed)
- Patients are not eligible if they are currently receiving treatment for lung cancer.
- Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment.
- Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). We ask participants to refrain from:
- Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling;
- Consume alcohol (including mouthwash) at least 8 hours before breath sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls
Time frame: 2 years
Using infrared cavity-ringdown spectroscopy, breath spectra of volatile organic compounds (VOCs) will be measured. Breath spectra will be statistically analyzed to identify features specific to each of the respective cohorts. These features will be used to train mathematical and statistical models to differentiate and categorize the samples within the three cohorts.
1 secondary outcome
Differences in breath spectra of patients with lung cancer before and after treatment
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Change in sponsor's business strategy (disease focus changed to breast cancer)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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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.
Nada Hammami study director
Vitalite Health Network
Marcel Mallet, MD principal investigator
Vitalite Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non Small Cell Lung Cancer, run by Breathe BioMedical Inc at 1 site in Canada.
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 1 inclusion and 5 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 31 May 2024. 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 Canada. 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: Change in sponsor's business strategy (disease focus changed to breast cancer)). 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?
Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls (time frame: 2 years). 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 31 May 2024.