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

Completed

• Conditions: Lung Cancer
• Interventions: Device: Portable GC device for brath analysis

• Registration Number: NCT06034730
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-08-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Cancer Patients	Portable GC device for brath analysis	patients undergoing surgery for histologically proven NSCLC
Healthy Control Patients	Portable GC device for brath analysis	patients undergoing surgery for benign extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative during preoperative evaluation.

Primary Outcome Measures

Name	Time	Method
Changes in VOCs peaks in patients with lung cancer vs healthy patients	24 hours	Identify biomarkers able to discriminate between lung cancer patients and healthy controls.

Trial Locations

Locations (1)

Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit; 🇮🇹 Bari, Italy