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Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy

Sponsor
Picomole Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04556435
Collaborator
University of California, Irvine (Other)
80
Enrollment
1
Location
25.6
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Analysis of Volatile Chemicals in the Breath of Lung Cancer Patients Using Infrared Spectroscopy
    Actual Study Start Date :
    Feb 25, 2021
    Anticipated Primary Completion Date :
    Mar 31, 2023
    Anticipated Study Completion Date :
    Apr 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. VOC spectral profile differences [30 days after completion]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mia Martinez Orange California United States 92868

    Sponsors and Collaborators

    • Picomole Inc
    • University of California, Irvine

    Investigators

    • Principal Investigator: Ali Mahtabifard, MD, University of California, Irvine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Picomole Inc
    ClinicalTrials.gov Identifier:
    NCT04556435
    Other Study ID Numbers:
    • 2019-5606
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Picomole Inc
    Volatile Organic Compounds
    Breath Analysis
    Infrared Spectroscopy
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Apr 20, 2022