Analysis of Volatile Chemicals in Lung Cancer Screen-Eligible Subjects Using Infrared Spectroscopy

November 14, 2023 updated by: Picomole Inc

The aim of this study is to sample and analyze volatile organic compounds (VOCs) from a high-risk population of subjects eligible for lung cancer screening as defined by the US Preventive Services Task Force (USPSTF) guidelines. The breath sample analysis will help investigators describe and identify real-world breath profiles from individuals at high risk of developing lung cancer and to use this to test machine learning (ML) algorithms for lung cancer screening. This study will also evaluate the feasibility and usability of Picomole's breath sampling technology in a mobile platform.

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

Lung cancer is the most common malignancy in the world in terms of both incidence and mortality (1.1 million new cases per year and 0.95 million deaths in males and 0.51 million new cases per year and 0.43 million deaths in females). The highest rates of lung cancer are found in Europe and North America. In addition, lung cancer is the leading cause of cancer death in Canada. Lung cancer is believed to develop slowly via a progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. When detected in the early stages, the 5-year survival rate for NSCLC is 57% to 61%, compared with a survival rate of approximately 6% once distant metastases are present. Unfortunately, most patients do not experience any signs or symptoms of lung cancer until the disease has progressed to an advanced stage. Therefore, technologies that facilitate detection of lung cancer in the earliest asymptomatic stages have significant potential to reduce lung cancer-specific mortality.

Malignant transformation is facilitated by deregulation of fundamental cellular processes, including alterations in metabolism. Thus, metabolomic profiling may be a promising strategy for identifying lung cancer before it is detectable via conventional methods such as CT scans. Breathomics is a field of study dedicated to deconstructing the metabolomic profile or biological components of volatile organic compounds (VOC) in breath. To date, various analytical techniques including gas chromatography combined with mass spectrometry, ion mobility spectrometry, proton transfer reaction spectrometry, and selected ion flow tube mass spectrometry have been used to study breath VOCs. In a recent study, ion mobility spectrometry discriminated between lung cancer and chronic obstructive lung disease with 79% accuracy, 76.8% sensitivity, and 85.7% specificity. Furthermore, breath analysis can be used to not only identify lung cancer but also distinguish between lung cancers with particular somatic mutations. For example, electronic nose technology demonstrated 79% and 85% sensitivity and specificity, respectively, for identifying EGFR-mutant lung cancer. These studies suggest that breath analysis is a highly sensitive and specific approach to detecting lung cancer.

This study will evaluate the performance characteristics of infrared spectroscopy for breath analysis. The spectrometer used to analyze breath gases is optimized to measure chemical concentrations down to the parts per trillion range. In a pilot study of 165 (67 newly diagnosed Non-Small Cell Lung Cancer (NSCLC) subjects which used infrared spectroscopy to analyze breath specimens from subjects with lung cancer and subjects without cancer, sensitivity and specificity for detecting lung cancer was 88.7% and 80%, respectively, with an accuracy of 86%. These preliminary results compare very favorably to mass spectrometry (the analytical platform that has been used in most breath analysis studies).

This study will analyze breath VOCs from 300 subjects who meet the USPSTF eligibility guidelines for lung cancer screening. The study aims to better understand the VOC breath profiles in a larger group of subjects at high risk for developing lung cancer. By restricting the population to screen-eligible subjects, this study will approximate the potential future "real world" use of this screening strategy and better approximate its utility in the field, sampling high risk populations in rural settings. It is envisioned that this study will generate preliminary data that will inform the performance of machine learning algorithms developed to detect the presence of lung cancer in unselected populations.

Study Type

Observational

Enrollment (Actual)

28

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
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

subjects who meet the USPSTF eligibility guidelines for lung cancer screening

Description

Inclusion Criteria:

  • Being screened for lung cancer on LUCAS;
  • At high-risk for lung cancer based on USPSTF guidelines:
  • Asymptomatic adults aged 50-80 years
  • Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes)
  • Current smoker or has quit smoking within the past 15 years.
  • No history of lung cancer or any other active cancer within 3 years (Note: DCIS, CIN, non-invasive bladder cancer, non-melanomatous skin cancers are an exception);
  • Ability to provide a breath sample;
  • Ability to give informed consent.

Exclusion Criteria:

  • Persons who cannot give informed consent or assent (i.e. mentally incompetent persons, or those physically incapacitated) or do not have a legally acceptable representative are not to be recruited into this study;
  • Persons who require the use of supplemental oxygen;
  • The breath sampling technology is sensitive to the chemicals produced by tobacco, cannabis, and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). So we ask that subjects refrain from Smoking (tobacco, cannabis, or e-cigarettes ) at least 4 hours before and consuming alcohol (including mouthwash) 8 hours before breath sampling

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
Screen-eligible Subjects
High-risk for lung cancer population who meet the USPSTF eligibility. One 10-L breath sample will be collected from each subject. During breath collection, subjects will be asked to exhale into a portable breath sampling device through a single use filter. Subjects will not be contacted to donate additional/serial breath specimens after the initial breath samples. Subjects will fill out a medical questionnaire and medical records will also be reviewed to extract low-dose CT scan (LDCT) screening results and any additional tumour-related information including histologic subtype, tumor stage, and sites of disease.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Picomole Inc

Collaborators

West Virginia University

Investigators

  • Principal Investigator: Kyle Chapman, MD, West Virginia University , Department of Medicine

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)

September 22, 2022

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 30, 2021

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

  • WVU010521

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.

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