Sniffing out cancer: new breath test aims to catch lung cancer early
NCT ID NCT04734145
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing a new technology called breathprinting, or electronic nose (e-nose), to see if it can detect early-stage lung cancer. Researchers will collect breath samples from 119 people with suspicious lung nodules before they have a biopsy or surgery. The goal is to see if the e-nose can accurately tell who has cancer and who doesn't, and whether it works better for larger tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Breathprinting test (e-nose)
- What this could lead to
- If successful, this could provide a simple, non-invasive breath test to help detect early-stage lung cancer, potentially leading to earlier diagnosis and treatment.
- What could go wrong
- This is a small, early-stage study (119 participants) testing a new technology. It may not be accurate enough to replace current diagnostic methods, and results may not apply to all types of lung cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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119 people
The number who actually took part.
- Started
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Jan 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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21 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). * 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 Exclusion Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Study Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
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