Lung CancerNCT06034730
Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer?
An observational study of Lung Cancer, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Portable GC device for brath analysis
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit
Bari, 70121
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Portable GC device for brath analysis
- Keywords
- breathomic, NSCLC, screening, volatile organic compounds
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable GC device for brath analysisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Patients | patients undergoing surgery for histologically proven NSCLC Receives: 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. Receives: Device: Portable GC device for brath analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in VOCs peaks in patients with lung cancer vs healthy patients
Identify biomarkers able to discriminate between lung cancer patients and healthy controls.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Apr 2021
- Primary completion1 Sep 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Humanitas Hospital, Italy
- Responsible party
- Sponsor
- Investigators
- Giuseppe Marulli, MD, PhD, Study director, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034730
- Sponsor's protocol ID
- 665139
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request alla data will be available
Publications
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.
PubMed 39226187
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06034730
- Acronym / sponsor ID
- 665139
- Conditions
- Lung Cancer
- Keywords
- breathomic, NSCLC, screening, volatile organic compounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- University of Michigan, Humanitas Hospital, Italy
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Patients | – | Device: Portable GC device for brath analysispatients undergoing surgery for histologically proven NSCLC |
| Healthy Control Patients | – | Device: Portable GC device for brath analysispatients undergoing surgery for benign extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative during preoperative evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable GC device for brath analysisPatients 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. | Device | Healthy Control Patients, Lung Cancer Patients |
Primary outcome
Changes in VOCs peaks in patients with lung cancer vs healthy patients
Time frame: 24 hours
Identify biomarkers able to discriminate between lung cancer patients and healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 39226187Brascia 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.
- Individual participant dataSharing planned: No. On request alla data will be available
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Marulli, MD, PhD study director
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in VOCs peaks in patients with lung cancer vs healthy patients (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.