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Active, not recruitingNCT04734145Updated May 6, 2026

Using e-Nose Technology to Identify Early Lung Cancer

An observational study in Lung; Node and Lung Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 7 sites in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
119
Ages
21 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Lung; Node
  • Lung Cancer

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Keywords

  • lung cancer
  • lung nodule
  • lung node
  • Memorial Sloan Kettering Caner Center
  • 20-349
  • Breathprinting
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 119 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

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Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
119 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Breathprinting test

Interventions

  • Diagnostic testBreathprinting test

    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.

    Also known as: E-Nose

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 1 month (time to biopsy)

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Study locations

7 sites
  • Memorial Sloan Kettering Basking Ridge (Consent only)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Monmouth (Consent only)
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Bergen (Consent only )
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (Consent only)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center (All Study Activities)
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau (Consent Only)
    Uniondale, New York 11553, United States
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References and documents

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 ↗

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04734145
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Feb 2, 2021
Start date
Jan 25, 2021
Primary completion
Jan 25, 2027 (estimated)
Completion
Jan 25, 2027 (estimated)
Last update
May 6, 2026

Study contacts

Gaetano Rocco, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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