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

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ClinicalTrials.gov Identifier: NCT05174468
Recruitment Status : Recruiting
First Posted : December 30, 2021
Last Update Posted : September 27, 2022
Sponsor:
Collaborator:
West Virginia University
Information provided by (Responsible Party):
Picomole Inc

Brief Summary:

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.


Condition or disease
Lung Cancer

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Volatile Chemicals in Lung Cancer Screen-Eligible Subjects Using Infrared Spectroscopy
Actual Study Start Date : September 22, 2022
Estimated Primary Completion Date : September 20, 2023
Estimated Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.



Primary Outcome Measures :
  1. VOC spectral profile differences [ Time Frame: within 30 days after collection ]
    VOC spectral profiles will be compared between cohorts to identify statistical differences


Biospecimen Retention:   Samples Without DNA
Volatile organic compounds (VOC) in breath are organic chemicals that are diffused or suspended at a room temperature. Breath samples will be collected into sorbent tubes that will be placed immediately (within ten minutes) after collection and stored in a freezer maintained at -1 to -10 degrees Fahrenheit and shipped on to Picomole headquarters for volatile chemical analysis using infrared spectroscopy.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects who meet the USPSTF eligibility guidelines for lung cancer screening
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05174468


Contacts
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Contact: Jenny R Ostien, MS 304-293-2370 jostien@hsc.wvu.edu
Contact: Kyle Chapman, MD 304-598-4855 kchapma4@hsc.wvu.edu

Locations
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United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Picomole Inc
West Virginia University
Investigators
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Principal Investigator: Kyle Chapman, MD West Virginia University , Department of Medicine
Additional Information:
Publications:
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Responsible Party: Picomole Inc
ClinicalTrials.gov Identifier: NCT05174468    
Other Study ID Numbers: WVU010521
First Posted: December 30, 2021    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Picomole Inc:
Breath Analysis
Volatile Organic Compounds
Infrared Spectroscopy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases