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

NCT06288646 | Terminated

• 1 other identifier: ROMEO 101712
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls

  Using infrared cavity-ringdown spectroscopy, breath spectra of volatile organic compounds (VOCs) will be measured. Breath spectra will be statistically analyzed to identify features specific to each of the respective cohorts. These features will be used to train mathematical and statistical models to differentiate and categorize the samples within the three cohorts.

  2 years

Secondary Outcomes (1)

• Differences in breath spectra of patients with lung cancer before and after treatment

  2 years

Study Arms (3)

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.

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.

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.

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

Study participants in all cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria. This study will enroll 30 patients from 3 different cohorts (confirmed NSCLS, stable pulmonary nodules, screened and negative controls). Additionally, a second breath sample may be taken from the 30 patients with lung cancer, totalling up to 120 breath samples.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Breathe BioMedical Inc: lead
• Vitalite Health Network: collaborator

Study Sites (1)

Vitalite Health Network

Moncton, New Brunswick, E1C 8X3, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled alveolar breath collected via a proprietary breath sampler

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

• Nada Hammami

  Vitalite Health Network

  STUDY DIRECTOR

• Marcel Mallet, MD

  Vitalite Health Network

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: March 1, 2024
• Study Start: April 24, 2023
• Primary Completion: April 16, 2024
• Study Completion: May 15, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CA (1)