Lung CancerNCT04556435
Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy
An observational study of Lung Cancer and Non Small Cell Lung Cancer, run by Breathe BioMedical Inc at 1 site in United States.
Trial summary
The aim of this study is to sample and analyze volatile organic compounds (VOCs) from lung cancer patients and individuals without lung cancer ("healthy" controls). The breath sample analysis will help investigators describe and identify profiles of VOCs found in the breath of patients with lung cancer when compared… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 4 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will analyze breath samples from study participants with diagnosed lung adenocarcinoma not currently receiving curative treatment and matched control participants without lung cancer. Prospective participants will be pre-screened prior to being approached about the study. Those scheduled for upcoming appointments will undergo a chart review to determine whether they meet eligibility criteria.
Who may be able to join
- LC Group:
- ≥ 18 years;
- Able to give informed consent;
- Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
- Clinical evidence of lung cancer (metastatic or primary), inclusive of those receiving non-curative treatment, has not yet been treated or is not currently on treatment;
- No history of or any other active cancer;
Show all 13Show fewer
- Able to provide a breath sample;
- Control Group:
- ≥ 18 years;
- Able to give informed consent;
- Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
- No history of lung cancer or any other active cancer and is eligible for lung cancer screening;
- Able to provide a breath sample;
Who cannot join
- Has received or is currently receiving curative treatment and may no longer have lung cancer;
- Cannot give informed consent;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Volatile Chemicals in the Breath of Lung Cancer Patients Using Infrared Spectroscopy
The aim of this study is to sample and analyze volatile organic compounds (VOCs) from lung cancer patients and individuals without lung cancer ("healthy" controls). The breath sample analysis will help investigators describe and identify profiles of VOCs found in the breath of patients with lung cancer when compared to normal breath profiles using infrared spectroscopy. This work will help validate early proof of concept results conducted with prototype technology and later stage NSCLC breath samples, and inform future breath testing analysis.
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
- Keywords
- Volatile Organic Compounds, Breath Analysis, Infrared Spectroscopy
- 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 |
|---|---|---|
| LC Group | Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health). Information related to LC diagnosis (histologic sub-type, tumor stage) will be collected. | |
| Control Group | Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health). |
What is being measured
The primary outcome is the main question the study is designed to answer.
VOC spectral profile differences
VOC spectral profiles will be compared between cohorts to identify statistical differences.
Measured: 30 days after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start25 Feb 2021
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Why it stopped: Change in the sponsor's business strategy (new focus on breast cancer)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breathe BioMedical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Ali Mahtabifard, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556435
- Sponsor's protocol ID
- 2019-5606
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Henderson B, Khodabakhsh A, Metsala M, Ventrillard I, Schmidt FM, Romanini D, Ritchie GAD, Te Lintel Hekkert S, Briot R, Risby T, Marczin N, Harren FJM, Cristescu SM. Laser spectroscopy for breath analysis: towards clinical implementation. Appl Phys B. 2018;124(8):161. doi: 10.1007/s00340-018-7030-x. Epub 2018 Jul 28.
PubMed 30956412
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Chemicals in the Breath of Lung Cancer Patients Using Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT04556435
- Acronym / sponsor ID
- 2019-5606
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Keywords
- Volatile Organic Compounds, Breath Analysis, Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in the sponsor's business strategy (new focus on breast cancer)
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Breathe BioMedical IncIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 21 Sep 2020 (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 aim of this study is to sample and analyze volatile organic compounds (VOCs) from lung cancer patients and individuals without lung cancer ("healthy" controls). The breath sample analysis will help investigators describe and identify profiles of VOCs found in the breath of patients with lung cancer when compared to normal breath profiles using infrared spectroscopy. This work will help validate early proof of concept results conducted with prototype technology and later stage NSCLC breath samples, and inform future breath testing analysis.
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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC Group | – | –Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health). Information related to LC diagnosis (histologic sub-type, tumor stage) will be collected. |
| Control Group | – | –Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will analyze breath samples from study participants with diagnosed lung adenocarcinoma not currently receiving curative treatment and matched control participants without lung cancer. Prospective participants will be pre-screened prior to being approached about the study. Those scheduled for upcoming appointments will undergo a chart review to determine whether they meet eligibility criteria.
Key inclusion criteria (13 listed)
- ≥ 18 years;
- Able to give informed consent;
- Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
- Clinical evidence of lung cancer (metastatic or primary), inclusive of those receiving non-curative treatment, has not yet been treated or is not currently on treatment;
- No history of or any other active cancer;
Key exclusion criteria (2 listed)
- Has received or is currently receiving curative treatment and may no longer have lung cancer;
- Cannot give informed consent;
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
VOC spectral profile differences
Time frame: 30 days after completion
VOC spectral profiles will be compared between cohorts to identify statistical differences.
Results and safety
The study was stopped early (reason given: Change in the sponsor's business strategy (new focus on breast cancer)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 30956412Henderson B, Khodabakhsh A, Metsala M, Ventrillard I, Schmidt FM, Romanini D, Ritchie GAD, Te Lintel Hekkert S, Briot R, Risby T, Marczin N, Harren FJM, Cristescu SM. Laser spectroscopy for breath analysis: towards clinical implementation. Appl Phys B. 2018;124(8):161. doi: 10.1007/s00340-018-7030-x. Epub 2018 Jul 28.
- American Cancer Society. Cancer Facts \& Figures 2019.Link provided by the sponsor.
- American Cancer Society. Non-Small Cell Lung Cancer Survival Rates (2016)Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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.
Ali Mahtabifard, MD principal investigator
University of California, Irvine
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 United States.
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 13 inclusion and 2 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 18 Nov 2023. 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 United States. 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 the sponsor's business strategy (new focus on 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?
VOC spectral profile differences (time frame: 30 days after completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556435, which also lists 2 linked publications.
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 18 Nov 2023.