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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Lung Cancer

Treatments: Device: Portable GC device for brath analysis

Study type: Observational

Funder types: Other

Identifiers

NCT06034730

665139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Lung Cancer Patients

Description:

patients undergoing surgery for histologically proven NSCLC

Treatment:

Device: Portable GC device for brath analysis

Healthy Control Patients

Description:

patients undergoing surgery for benign extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative during preoperative evaluation.

Treatment:

Device: Portable GC device for brath analysis