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Clinical Trials/NCT06034730
NCT06034730
Completed
N/A

Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer? An Exploratory Study on a Cohort of 60 Patients

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari1 site in 1 country60 target enrollmentApril 1, 2021
ConditionsLung Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Enrollment
60
Locations
1
Primary Endpoint
Changes in VOCs peaks in patients with lung cancer vs healthy patients
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed Description

The breath of patients with histologically proven NSCLC and healthy controls was sampled into Tedlar bags through a Nafion filter and a one-way mouthpiece. The breath samples in the bags were then analyzed by an automated micro portable gas chromatography device developed in-house, which consisted of a thermal desorption tube, thermal injector, separation column, and photoionization detector, as well as other accessories such as pumps, valves, and a helium cartridge. The chromatograms were analyzed by chemometrics and machine learning techniques.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • NSCLC histologically proven (for LC group) at any stage of disease
  • non-cancer controls who had negative findings on preoperative chest X-rays/chest CT scan (for HC groups)

Exclusion Criteria

  • Patients who had any history of another type of cancer
  • who had received neoadjuvant chemo/radiotherapy because of the possible unknown effects on cancer metabolism
  • pediatric patients.

Outcomes

Primary Outcomes

Changes in VOCs peaks in patients with lung cancer vs healthy patients

Time Frame: 24 hours

Identify biomarkers able to discriminate between lung cancer patients and healthy controls.

Study Sites (1)

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