Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy

November 14, 2023 updated by: Picomole Inc

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Mia Martinez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VOC spectral profile differences
Time Frame: 30 days after completion
VOC spectral profiles will be compared between cohorts to identify statistical differences.
30 days after completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Picomole Inc

Collaborators

University of California, Irvine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2021

Primary Completion (Actual)

August 4, 2023

Study Completion (Actual)

August 4, 2023

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-5606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe