Lung; NodeNCT04734145
Using e-Nose Technology to Identify Early Lung Cancer
An observational study of Lung; Node and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to test the ability of a new technology called breathprinting, or electronic nose (e-nose), to detect early-stage lung cancer. Additionally, researchers also want to see if the e-nose technology is more effective at diagnosing lung cancer if the tumor size is larger. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Lung; Node, Lung Cancer
- What is being tested?
- Breathprinting test
- How many people
- 119 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Jan 2021to 25 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the principal investigator (PI), or the research team at MSK. If the PI is a member of the treatment team, he or she will screen his or her patients' medical records for suitable research study participants, and discuss the study and the patient's potential for enrolling in the research study with the patient. Potential subjects contacted by their treating physician will be referred to the PI/research staff to record appropriate contact information, so that these patients can be approached about enrolling in the study.
Who may be able to join
- Age 21-85
- Single, monolateral nodule of at least 50% solid composition visible on chest CT scan (with or without contrast) suspicious for lung cancer.
- MSK radiologist report or read suggestive (i.e. at least 50% certainty) of suspected primary lung cancer (in accordance with the level of certainty criteria set forth by MSKCC Radiology)
- o Patients with biopsy-proven early stage, primary lung cancer that meets staging requirements, do not need to also have a radiology report meeting inclusion criteria
- Negative test for COVID-19 performed locally or at MSK, done as part of standard of care testing (i.e. only when required by specific institutional policy) prior to biopsy or surgical procedure
- Eligible for fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis (i.e., does not have comorbidities precluding these).
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- Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study
- o Patient must agree to undergo fine-needle aspiration biopsy, robotic bronchoscopy, and/or surgical resection for diagnosis prior to e-nose collectionNote: Biopsy-proven patients that meet eligible staging criteria who are not further surgical candidates will be collected prior to next step in standard of care treatment
- Patients with biopsy-proven clinical stage I lung cancer are eligible if the biopsy is done within 6 weeks of the consent date
Who cannot join
- Age <21 and >85 years at first outpatient visit.
- Multiple ipsilateral or bilateral nodules reported on chest CT scan and/or concurrent as suspicious for lung cancer (note: nodules deemed indeterminate, inflammatory, etc. will not exclude a patient from participating in this study) semisolid GGOs.
- Lung nodule of interest is less than 50% solid in composition
- Per MSK radiologist report or read, the lung nodule of interest is "less likely" or "unlikely" (i.e. less than 50% certainty) to be neoplastic (in accordance with the level of certainty criteria set forth by MSKCC Radiology)
- Any previous history of lung cancer
- History of any non-lung cancer(s) that is currently being treated (note: prior history of completely treated non-lung cancer from any time will be eligible)
- Metastatic lung cancer disease seen on chest CT or PET scan at hilar/mediastinal nodes or contralateral lung or extrathoracic sites.
- Previous medical history of a lung biopsy/surgical procedure for cancer diagnosis (note: patients who underwent a lung biopsy over three years ago that showed negative for lung cancer and patients who underwent a lung biopsy confirming stage I lung cancer within the past 6 weeks will be eligible)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Study Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
About this study
Official title: Breathprinting (e-Nose) Technology for the Identification of Early-Stage Lung Cancer
The purpose of this study is to test the ability of a new technology called breathprinting, or electronic nose (e-nose), to detect early-stage lung cancer. Additionally, researchers also want to see if the e-nose technology is more effective at diagnosing lung cancer if the tumor size is larger.
- Conditions
- Lung; Node, Lung Cancer
- Being tested
- Breathprinting test
- Keywords
- lung cancer, lung nodule, lung node, Memorial Sloan Kettering Caner Center, 20-349, Breathprinting
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathprinting testDiagnostic test
Also called E-Nose
Consented, enrolled participants will undergo a breathprinting test (e-nose) during the presurgical visit and at the same facility as their presurgical or prebiopsy visit, before any attempt is made to obtain cytohistological diagnosis of the pulmonary nodule.
| Study group | Role | What they receive |
|---|---|---|
| Participants with an Undiagnosed Pulmonary Nodule | One hundred evaluable individuals aged 21 to 85 years with a single undiagnosed pulmonary nodule measuring <3 cm, clinically staged as cT1N0M0 (eighth edition of the TNM staging manual) by CT and PET scans, will be enrolled in this diagnostic study and will undergo e-nose testing. These patients must have a risk assessment profile that, according to institutional guidelines, identifies them as candidates for subsequent surgical resection of the pulmonary nodule, which will confirm the results of the breathprinting analysis. Receives: Diagnostic Test: Breathprinting test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease status determined by e-nose testing
For each study participant, disease status will be determined by e-nose testing ("cancer" or "no cancer") and by TTNA or surgery ("true" status).
Measured: up to 1 month (time to biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start25 Jan 2021
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung; NodeStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetano Rocco, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734145
- Sponsor's protocol ID
- 20-349
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2021
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Rocco G, Pennazza G, Tan KS, Vanstraelen S, Santonico M, Corba RJ, Park BJ, Sihag S, Bott MJ, Crucitti P, Isbell JM, Ginsberg MS, Weiss H, Incalzi RA, Finamore P, Longo F, Zompanti A, Grasso S, Solomon SB, Vincent A, McKnight A, Cirelli M, Voli C, Kelly S, Merone M, Molena D, Gray K, Huang J, Rusch VW, Bains MS, Downey RJ, Adusumilli PS, Jones DR. A Real-World Assessment of Stage I Lung Cancer Through Electronic Nose Technology. J Thorac Oncol. 2024 Sep;19(9):1272-1283. doi: 10.1016/j.jtho.2024.05.006. Epub 2024 May 16.
PubMed 38762120
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathprinting (e-Nose) Technology for the Identification of Early-Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT04734145
- Acronym / sponsor ID
- 20-349
- Conditions
- Lung; Node, Lung Cancer
- Keywords
- lung cancer, lung nodule, lung node, Memorial Sloan Kettering Caner Center, 20-349, Breathprinting
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 2 Feb 2021 (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 purpose of this study is to test the ability of a new technology called breathprinting, or electronic nose (e-nose), to detect early-stage lung cancer. Additionally, researchers also want to see if the e-nose technology is more effective at diagnosing lung cancer if the tumor size is larger.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with an Undiagnosed Pulmonary Nodule | – | Diagnostic Test: Breathprinting testOne hundred evaluable individuals aged 21 to 85 years with a single undiagnosed pulmonary nodule measuring <3 cm, clinically staged as cT1N0M0 (eighth edition of the TNM staging manual) by CT and PET scans, will be enrolled in this diagnostic study and will undergo e-nose testing. These patients must have a risk assessment profile that, according to institutional guidelines, identifies them as candidates for subsequent surgical resection of the pulmonary nodule, which will confirm the results of the breathprinting analysis. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the principal investigator (PI), or the research team at MSK. If the PI is a member of the treatment team, he or she will screen his or her patients' medical records for suitable research study participants, and discuss the study and the patient's potential for enrolling in the research study with the patient. Potential subjects contacted by their treating physician will be referred to the PI/research staff to record appropriate contact information, so that these patients can be approached about enrolling in the study.
Key inclusion criteria (9 listed)
- Age 21-85
- Single, monolateral nodule of at least 50% solid composition visible on chest CT scan (with or without contrast) suspicious for lung cancer.
- MSK radiologist report or read suggestive (i.e. at least 50% certainty) of suspected primary lung cancer (in accordance with the level of certainty criteria set forth by MSKCC Radiology)
- o Patients with biopsy-proven early stage, primary lung cancer that meets staging requirements, do not need to also have a radiology report meeting inclusion criteria
- Negative test for COVID-19 performed locally or at MSK, done as part of standard of care testing (i.e. only when required by specific institutional policy) prior to biopsy or surgical procedure
Key exclusion criteria (8 listed)
- Age <21 and >85 years at first outpatient visit.
- Multiple ipsilateral or bilateral nodules reported on chest CT scan and/or concurrent as suspicious for lung cancer (note: nodules deemed indeterminate, inflammatory, etc. will not exclude a patient from participating in this study) semisolid GGOs.
- Lung nodule of interest is less than 50% solid in composition
- Per MSK radiologist report or read, the lung nodule of interest is "less likely" or "unlikely" (i.e. less than 50% certainty) to be neoplastic (in accordance with the level of certainty criteria set forth by MSKCC Radiology)
- Any previous history of lung cancer
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 |
|---|---|---|
| Breathprinting testAlso: E-NoseConsented, enrolled participants will undergo a breathprinting test (e-nose) during the presurgical visit and at the same facility as their presurgical or prebiopsy visit, before any attempt is made to obtain cytohistological diagnosis of the pulmonary nodule. | Diagnostic test | Participants with an Undiagnosed Pulmonary Nodule |
Primary outcome
Disease status determined by e-nose testing
Time frame: up to 1 month (time to biopsy)
For each study participant, disease status will be determined by e-nose testing ("cancer" or "no cancer") and by TTNA or surgery ("true" status).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 38762120Rocco G, Pennazza G, Tan KS, Vanstraelen S, Santonico M, Corba RJ, Park BJ, Sihag S, Bott MJ, Crucitti P, Isbell JM, Ginsberg MS, Weiss H, Incalzi RA, Finamore P, Longo F, Zompanti A, Grasso S, Solomon SB, Vincent A, McKnight A, Cirelli M, Voli C, Kelly S, Merone M, Molena D, Gray K, Huang J, Rusch VW, Bains MS, Downey RJ, Adusumilli PS, Jones DR. A Real-World Assessment of Stage I Lung Cancer Through Electronic Nose Technology. J Thorac Oncol. 2024 Sep;19(9):1272-1283. doi: 10.1016/j.jtho.2024.05.006. Epub 2024 May 16.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Gaetano Rocco, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung; Node and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Disease status determined by e-nose testing (time frame: up to 1 month (time to biopsy)). 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 NCT04734145, which also lists 1 linked publication.
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 6 May 2026.