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Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer?

NCT06034730 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-09-13

No results posted yet for this study

Summary

Breath analysis examining specific patterns of volatile organic compounds (VOCs) has been demonstrated to be able to discriminate lung cancer (LC) patients from healthy controls (HC). However, the existing technology uses complex, expensive, and low throughput analytical platforms to give an offline response, thus preventing its applicability for mass screening. The reliability of a new portable device to enable rapid, on-site LC diagnosis is tested.

Conditions

Interventions

DEVICE

Portable GC device for brath analysis

Patients were asked to orally exhale 1-2 L breath into a 5 L Tedlar bag via a one-way mouthpiece and Nafion filter for moisture removal, as shown in Figure 1B. The process usually takes about a few minutes. The breath analysis took place either in-situ immediately after the breath sample collection or within 24 h of breath collection. The Tedlar bags were stored under ambient condition until analyzed. During the breath analysis, the Tedlar bag was connected to the sampling port of the portable GC (Figure 1C). Approximately 350 mL of breath was pulled from the Tedlar bag into the GC for analysis. The GC operation was controlled using LabView via a laptop. The total assay time was 30 min, including 5 min of breath sampling time from the Tedlar bag at a flow rate of 70 mL/min (see the blue path in Figure 1A), 5 min of desorption/transfer time, 10 min of chromatographic separation time (see the orange path in Figure 1A), and 10 min of GC system cleaning time.

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • Humanitas Hospital, Italy

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Principal Investigators

  • Giuseppe Marulli, MD, PhD · Humanitas Research Hospital IRCCS, Rozzano-Milan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-09-01
Completion
2023-08-01

Countries

  • Italy

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034730 on ClinicalTrials.gov