Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy

NCT04556435 | Terminated

• 1 other identifier: 2019-5606
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to sample and analyze volatile organic compounds (VOCs) from lung cancer patients and individuals without lung cancer ("healthy" controls). The breath sample analysis will help investigators describe and identify profiles of VOCs found in the breath of patients 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; Non Small Cell Lung Cancer

Keywords

Volatile Organic Compounds; Breath Analysis; Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• VOC spectral profile differences

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

  30 days after completion

Study Arms (2)

LC Group

Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health). Information related to LC diagnosis (histologic sub-type, tumor stage) will be collected.

Control Group

Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health).

Eligibility Criteria

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

Study Population

This study will analyze breath samples from study participants with diagnosed lung adenocarcinoma not currently receiving curative treatment and matched control participants without lung cancer. Prospective participants will be pre-screened prior to being approached about the study. Those scheduled for upcoming appointments will undergo a chart review to determine whether they meet eligibility criteria.

You may qualify if:

• LC Group:
• ≥ 18 years;
• Able to give informed consent;
• Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
• Clinical evidence of lung cancer (metastatic or primary), inclusive of those receiving non-curative treatment, has not yet been treated or is not currently on treatment;
• No history of or any other active cancer;
• Able to provide a breath sample;
• Control Group:
• ≥ 18 years;
• Able to give informed consent;
• Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
• No history of lung cancer or any other active cancer and is eligible for lung cancer screening;
• Able to provide a breath sample;

You may not qualify if:

• Has received or is currently receiving curative treatment and may no longer have lung cancer;
• Cannot give informed consent;

Sponsors & Collaborators

• Breathe BioMedical Inc: lead
• University of California, Irvine: collaborator

Study Sites (1)

Mia Martinez

Orange, California, 92868, United States

Location

Related Publications (2)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Henderson B, Khodabakhsh A, Metsala M, Ventrillard I, Schmidt FM, Romanini D, Ritchie GAD, Te Lintel Hekkert S, Briot R, Risby T, Marczin N, Harren FJM, Cristescu SM. Laser spectroscopy for breath analysis: towards clinical implementation. Appl Phys B. 2018;124(8):161. doi: 10.1007/s00340-018-7030-x. Epub 2018 Jul 28.

  PMID: 30956412 BACKGROUND

Related Links

• American Cancer Society. Cancer Facts \& Figures 2019.
• American Cancer Society. Non-Small Cell Lung Cancer Survival Rates (2016)

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Ali Mahtabifard, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: February 25, 2021
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)