Clinical trial · Observational
Analysis of Volatile Chemicals in Lung Cancer Screen-Eligible Subjects Using Infrared Spectroscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in sponsor's business strategy (disease focus changed to breast cancer)
Summary
Brief summary (as posted)
The aim of this study is to sample and analyze volatile organic compounds (VOCs) from a high-risk population of subjects eligible for lung cancer screening as defined by the US Preventive Services Task Force (USPSTF) guidelines. The breath sample analysis will help investigators describe and identify real-world breath profiles from individuals at high risk of developing lung cancer and to use this to test machine learning (ML) algorithms for lung cancer screening. This study will also evaluate the feasibility and usability of Picomole's breath sampling technology in a mobile platform. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Screen-eligible Subjects
- description
- High-risk for lung cancer population who meet the USPSTF eligibility. One 10-L breath sample will be collected from each subject. During breath collection, subjects will be asked to exhale into a portable breath sampling device through a single use filter. Subjects will not be contacted to donate additional/serial breath specimens after the initial breath samples. Subjects will fill out a medical questionnaire and medical records will also be reviewed to extract low-dose CT scan (LDCT) screening results and any additional tumour-related information including histologic subtype, tumor stage, and sites of disease.
Primary outcomes (1)
- measure
- VOC spectral profile differences
- timeFrame
- within 30 days after collection
- description
- VOC spectral profiles will be compared between cohorts to identify statistical differences
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Being screened for lung cancer on LUCAS; * At high-risk for lung cancer based on USPSTF guidelines: * Asymptomatic adults aged 50-80 years * Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes) * Current smoker or has quit smoking within the past 15 years. * No history of lung cancer or any other active cancer within 3 years (Note: DCIS, CIN, non-invasive bladder cancer, non-melanomatous skin cancers are an exception); * Ability to provide a breath sample; * Ability to give informed consent. Exclusion Criteria: * Persons who cannot give informed consent or assent (i.e. mentally incompetent persons, or those physically incapacitated) or do not have a legally acceptable representative are not to be recruited into this study; * Persons who require the use of supplemental oxygen; * The breath sampling technology is sensitive to the chemicals produced by tobacco, cannabis, and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). So we ask that subjects refrain from Smoking (tobacco, cannabis, or e-cigarettes ) at least 4 hours before and consuming alcohol (including mouthwash) 8 hours before breath sampling
References
Publications (5)
- BACKGROUNDJemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. PMID 21296855
- BACKGROUNDBoots AW, van Berkel JJ, Dallinga JW, Smolinska A, Wouters EF, van Schooten FJ. The versatile use of exhaled volatile organic compounds in human health and disease. J Breath Res. 2012 Jun;6(2):027108. doi: 10.1088/1752-7155/6/2/027108. Epub 2012 May 23. PMID 22621865
- BACKGROUNDShlomi D, Abud M, Liran O, Bar J, Gai-Mor N, Ilouze M, Onn A, Ben-Nun A, Haick H, Peled N. Detection of Lung Cancer and EGFR Mutation by Electronic Nose System. J Thorac Oncol. 2017 Oct;12(10):1544-1551. doi: 10.1016/j.jtho.2017.06.073. Epub 2017 Jul 12. PMID 28709937
- BACKGROUNDSchmidt FM, Metsala M, Vaittinen O, Halonen L. Background levels and diurnal variations of hydrogen cyanide in breath and emitted from skin. J Breath Res. 2011 Dec;5(4):046004. doi: 10.1088/1752-7155/5/4/046004. Epub 2011 Aug 2. PMID 21808098
- BACKGROUNDChen W, Metsala M, Vaittinen O, Halonen L. Hydrogen cyanide in the headspace of oral fluid and in mouth-exhaled breath. J Breath Res. 2014 Jun;8(2):027108. doi: 10.1088/1752-7155/8/2/027108. Epub 2014 May 21. PMID 24844251