Clinical trial NCT06034730: Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer?
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: breathomic
NSCLC
screening
volatile organic compounds
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Humanitas Hospital, Italy
First posted: 2023-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Changes in VOCs peaks in patients with lung cancer vs healthy patients
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Giuseppe Marulli, MD, PhD
role: STUDY_DIRECTOR
References: