Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy

Lung Cancer Clinical Trial

Official title:

Analysis of Volatile Chemicals in the Breath of Lung Cancer Patients Using Infrared Spectroscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04556435
• Other study ID #: 2019-5606
• Status: Terminated
• Start date: February 25, 2021
• Est. completion date: August 4, 2023

Study information

• Verified date: November 2023
• Source: Picomole Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
United States	Mia Martinez	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
Picomole Inc	University of California, Irvine

Country where clinical trial is conducted

United States, 

References & 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. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VOC spectral profile differences	VOC spectral profiles will be compared between cohorts to identify statistical differences.	30 days after completion

External Links

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