Analysis of Volatile Chemicals in Lung Cancer Screen-Eligible Subjects Using Infrared Spectroscopy
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.
Checked against the public recordLast updated Nov 18, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Breathe BioMedical Inc
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- West Virginia UniversityMorgantown, West Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 18, 2023. Always confirm current availability with the study team.