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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034730
• Other study ID #: 665139
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit	Bari

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	Humanitas Hospital, Italy, University of Michigan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in VOCs peaks in patients with lung cancer vs healthy patients	Identify biomarkers able to discriminate between lung cancer patients and healthy controls.	24 hours