Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer

NCT ID: NCT06288646

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2024-05-15

Brief Summary

The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.

Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.

Detailed 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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Confirmed Lung Cancer

To be eligible for the lung cancer group:

• Aged 50 and over;
• Current or former smoker with smoking history ≥ 20 pack-years;
• Capacity to give informed consent;
• Non-metastatic non-small cell lung cancer, that has not been treated
• No history of active cancer in the past 5 years (exceptions include: Ductal carcinoma in situ (DCIS), cervical intraepithelial neoplasia (CIN), non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6);
• Able to provide a breath sample.

To be eligible for a second breath sample:

• Same as above, in addition to, and with the exception of criterion 4:
• Non-metastatic non-small cell lung cancer, which has undergone surgical resection;
• 6 months since completion of surgery, radiation, and chemotherapy on primary NSCLC;
• CT scan at least 6 months after surgical resection, confirming the absence of lung cancer.

No interventions assigned to this group

Control

For a participant to be eligible in the study control group:

• Aged 50 and over;
• Current or former smoker with smoking history ≥ 20 pack-years;
• Capacity to give informed consent;
• No history of active lung cancer;
• No pulmonary nodule(s);
• No active cancer in the last 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason ≤ 6 prostate cancer will be exceptions);
• Ability to provide a breath sample.

No interventions assigned to this group

Stable pulmonary nodule

For a participant to be eligible for admission to the stable lung nodules group:

• Aged 50 and over;
• Current or former smoker with smoking history ≥ 20 pack-years;
• Capacity to give informed consent;
• No history of active lung cancer or other active cancer in the past 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6 or lower will be exceptions);
• Presence of one or more stable lung nodules (as determined by the principal investigator);
• Ability to provide a breath sample.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.

Exclusion Criteria

• Patients are not eligible if they are currently receiving treatment for lung cancer.
• Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment.

Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). We ask participants to refrain from:

• Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling;
• Consume alcohol (including mouthwash) at least 8 hours before breath sampling.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vitalite Health Network

UNKNOWN

Sponsor Role: collaborator

Breathe BioMedical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nada Hammami

Role: STUDY_DIRECTOR

Vitalite Health Network

Marcel Mallet, MD

Role: PRINCIPAL_INVESTIGATOR

Vitalite Health Network

Locations

Vitalite Health Network

Moncton, New Brunswick, Canada

Countries

Canada

Other Identifiers

ROMEO 101712

Identifier Type: -

Identifier Source: org_study_id