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

NCT06034730 | Completed

• 1 other identifier: 665139
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

breathomic; NSCLC; screening; volatile organic compounds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lung Cancer Patients

patients undergoing surgery for histologically proven NSCLC

Device: Portable GC device for brath analysis

Healthy Control Patients

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

Device: Portable GC device for brath analysis

Interventions

Portable GC device for brath analysis DEVICE

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.

Healthy Control Patients; Lung Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 60 patients undergoing surgery for histologically proven NSCLC and a comparative group of non-cancer controls who had negative findings on preoperative chest X-rays/chest CT scan were admitted to our Thoracic Surgery Unit between August 2021 and March 2022. Patients underwent breath collection during the pre-hospitalization analysis before surgery. The control group was recruited from patients undergoing surgery for benign extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative during preoperative evaluation. Patients excluded from analysis were those who had any history of another type of cancer and those who had received neoadjuvant chemo/radiotherapy because of the possible unknown effects on cancer metabolism.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• University of Michigan: collaborator
• Humanitas Hospital, Italy: collaborator

Study Sites (1)

Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit

Bari, 70121, Italy

Location

Related Publications (1)

• Brascia D, De Iaco G, Panza T, Signore F, Carleo G, Zang W, Sharma R, Riahi P, Scott J, Fan X, Marulli G. Breathomics: may it become an affordable, new tool for early diagnosis of non-small-cell lung cancer? An exploratory study on a cohort of 60 patients. Interdiscip Cardiovasc Thorac Surg. 2024 Sep 4;39(3):ivae149. doi: 10.1093/icvts/ivae149.

  PMID: 39226187 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath from the patients, retained for a maximum of 24h

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Giuseppe Marulli, MD, PhD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 13, 2023
• Study Start: April 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: August 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)