Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathprinting test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 1 month (time to biopsy) |
Not provided
Not provided
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:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gaetano Rocco, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | 07920 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38762120 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |