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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Humanitas Hospital, Italy | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Cancer Patients | patients undergoing surgery for histologically proven NSCLC |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Marulli, MD, PhD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit | Bari | 70121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39226187 | Derived | 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. |
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On request alla data will be available
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Breath from the patients, retained for a maximum of 24h
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |