Analysis of Volatile Chemicals in Lung Cancer Screen-Eligible Subjects Using Infrared Spectroscopy

NCT05174468 | Terminated

• 1 other identifier: WVU010521
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer

Keywords

Breath Analysis; Volatile Organic Compounds; Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• VOC spectral profile differences

  VOC spectral profiles will be compared between cohorts to identify statistical differences

  within 30 days after collection

Study Arms (1)

Screen-eligible Subjects

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects who meet the USPSTF eligibility guidelines for lung cancer screening

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Breathe BioMedical Inc: lead
• West Virginia University: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (5)

• Jemal 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 BACKGROUND

• Boots 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 BACKGROUND

• Shlomi 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 BACKGROUND

• Schmidt 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 BACKGROUND

• Chen 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 BACKGROUND

Related Links

• American Cancer Society. Cancer Facts \& Figures 2019. Atlanta: American Cancer Society
• Canadian Cancer Statistics 2019
• The American Cancer Society (2016). Non-Small Cell Lung Cancer Survival Rates.
• \[Abstract\] Janssens E, Lamote K, van Meerbeeck JP (2018). Breath analysis by ion mobility spectrometry allows to discriminate COPD from lung cancer patients. European Respiratory Journal. 52: Suppl. 62,

Biospecimen

Retention: SAMPLES WITHOUT DNA

Volatile organic compounds (VOC) in breath are organic chemicals that are diffused or suspended at a room temperature. Breath samples will be collected into sorbent tubes that will be placed immediately (within ten minutes) after collection and stored in a freezer maintained at -1 to -10 degrees Fahrenheit and shipped on to Picomole headquarters for volatile chemical analysis using infrared spectroscopy.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kyle Chapman, MD

  West Virginia University , Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: September 22, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)