Non-small Cell Lung CancerNCT04948047
Breath Combined With CT for Diagnoses of Pulmonary Nodules
An observational study of Non-small Cell Lung Cancer and Pulmonary Nodule, Multiple, run by Peking University People's Hospital at 1 site in China.
Trial summary
Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Pulmonary Nodule, Multiple
- What is being tested?
- Pathological examinations as the golden diagnosis criteria and Breath test combined with computed tomography
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2021to 31 Dec 2022
- 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
- Adult, Older adult
Study population: To establish pulmonary nodule diagnosis model of breath test combined with computed tomography, we reviewed the prospective database established during the study of NCT04419207 for participant recruitment. 200 participants with malignant pulmonary nodules and 200 patients with benign pulmonary nodules will be included for establishing the diagnosis model. To validate the efficacy of the established model in distinguishing malignant pulmonary nodules from benign nodules, we will prospectively recruit 500 patients with pulmonary nodules in multi centers: Peking University People's Hospital (200 participants), The First Affiliated Hospital of Zhengzhou University (200 participants), and Beijing Haidian Hospital (100 participants).
Who may be able to join
- Age > 18 years old;
- Pulmonary nodules with planned surgical resection;
- Signed informed consent and agreed to participate in this study.
Who cannot join
- Preoperative radiotherapy, chemotherapy, targeted therapy or other anti-tumor therapy
- The lack of chest computed tomography within two weeks before surgery
- A history of malignant disease within 5 years.
Trial locations and contacts
1 site in 1 country.
Peiyu Wang, MM contact
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Mantang Qiu, PhD, qiumantang@163.com
About this study
Official title: Assessment of the Efficacy of Breath Test Combined With Computed Tomography for Diagnoses of Pulmonary Nodules.
Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining breath test with chest computed tomography (CT). This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from exhaled breath and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be validated prospectively.
Read the detailed description
Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer. Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining VOC analysis with chest computed tomography.
In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of patients with pulmonary nodules. The chest CT will be used for detecting the imaging characteristics of pulmonary nodules. The pathological diagnosis of pulmonary nodules after surgical resections is selected as golden standard.
This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from breath test and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be varied prospectively.
- Being tested
- Pathological examinations as the golden diagnosis criteria, Breath test combined with computed tomography
- Keywords
- volatile organic compound, pulmonary nodules, predictive model, computed tomography, HPPI-TOFMS
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathological examinations as the golden diagnosis criteriaDiagnostic test
Pathological diagnosis, as the golden standard for diagnosing pulmonary nodules, is achieved by two experienced pathologists and validated by the third senior pathologist.
Breath test combined with computed tomographyDiagnostic test
Exhaled breath of each participant will be collected with Tedlar bags. The volatile organic compounds will be detected by a high-resolution high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS).
The Imaging markers of pulmonary nodules, including the size, three-dimensional shape, and appearance characteristics, are derived from the chest computed tomography within 2 weeks before surgery resection.
| Study group | Role | What they receive |
|---|---|---|
| Malignant pulmonary nodules | Patients with pulmonary nodule diagnosed as malignant cancer by pathological examinations after surgical resection. Receives: Diagnostic Test: Pathological examinations as the golden diagnosis criteria; Diagnostic Test: Breath test combined with computed tomography | |
| Benign pulmonary nodules | Patients with pulmonary nodule diagnosed as benign disease by pathological examinations after surgical resection. Receives: Diagnostic Test: Pathological examinations as the golden diagnosis criteria; Diagnostic Test: Breath test combined with computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
Measured: 8 weeks
Diagnostic specificity of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
Measured: 8 weeks
Diagnostic accuracy of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic accuracy of breath test combined with computed tomography will be calculated
Measured: 8 weeks
Secondary outcomes (2)
Positive predictive value of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, positive predictive value of breath test combined with computed tomography will be calculated
Measured: 8 weeks
Negative predictive value of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, negative predictive value of breath test combined with computed tomography will be calculated
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start10 Jul 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangsu Cancer Institute & Hospital, Beijing Breatha Biological Technology Co., Ltd, Beijing
- Responsible party
- Principal investigator, Mantang Qiu, MD, PhD, Peking University People's Hospital
- Investigators
- Mantang Qiu, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948047
- Sponsor's protocol ID
- 2021PHB150-001
- Status last verified
- Apr 2022
- First submitted
- 24 Jun 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Breath Test Combined With Computed Tomography for Diagnoses of Pulmonary Nodules.
- ClinicalTrials.gov ID
- NCT04948047
- Acronym / sponsor ID
- 2021PHB150-001
- Keywords
- volatile organic compound, pulmonary nodules, predictive model, computed tomography, HPPI-TOFMS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital, The First Affiliated Hospital of Zhengzhou University, Jiangsu Cancer Institute & Hospital, Beijing Breatha Biological Technology Co., Ltd, Beijing
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Jul 2021 (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.
Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining breath test with chest computed tomography (CT). This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from exhaled breath and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be validated prospectively.
Detailed description
Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer. Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining VOC analysis with chest computed tomography.
In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of patients with pulmonary nodules. The chest CT will be used for detecting the imaging characteristics of pulmonary nodules. The pathological diagnosis of pulmonary nodules after surgical resections is selected as golden standard.
This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from breath test and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be varied prospectively.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant pulmonary nodules | – | Diagnostic Test: Pathological examinations as the golden diagnosis criteria, Diagnostic Test: Breath test combined with computed tomographyPatients with pulmonary nodule diagnosed as malignant cancer by pathological examinations after surgical resection. |
| Benign pulmonary nodules | – | Diagnostic Test: Pathological examinations as the golden diagnosis criteria, Diagnostic Test: Breath test combined with computed tomographyPatients with pulmonary nodule diagnosed as benign disease by pathological examinations after surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- To establish pulmonary nodule diagnosis model of breath test combined with computed tomography, we reviewed the prospective database established during the study of NCT04419207 for participant recruitment. 200 participants with malignant pulmonary nodules and 200 patients with benign pulmonary nodules will be included for establishing the diagnosis model. To validate the efficacy of the established model in distinguishing malignant pulmonary nodules from benign nodules, we will prospectively recruit 500 patients with pulmonary nodules in multi centers: Peking University People's Hospital (200 participants), The First Affiliated Hospital of Zhengzhou University (200 participants), and Beijing Haidian Hospital (100 participants).
Key inclusion criteria (3 listed)
- Age > 18 years old;
- Pulmonary nodules with planned surgical resection;
- Signed informed consent and agreed to participate in this study.
Key exclusion criteria (3 listed)
- Preoperative radiotherapy, chemotherapy, targeted therapy or other anti-tumor therapy
- The lack of chest computed tomography within two weeks before surgery
- A history of malignant disease within 5 years.
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 |
|---|---|---|
| Pathological examinations as the golden diagnosis criteriaPathological diagnosis, as the golden standard for diagnosing pulmonary nodules, is achieved by two experienced pathologists and validated by the third senior pathologist. | Diagnostic test | Benign pulmonary nodules, Malignant pulmonary nodules |
| Breath test combined with computed tomographyExhaled breath of each participant will be collected with Tedlar bags. The volatile organic compounds will be detected by a high-resolution high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS). The Imaging markers of pulmonary nodules, including the size, three-dimensional shape, and appearance characteristics, are derived from the chest computed tomography within 2 weeks before surgery resection. | Diagnostic test | Benign pulmonary nodules, Malignant pulmonary nodules |
Primary outcome
Diagnostic sensitivity of breath test combined with computed tomography
Time frame: 8 weeks
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
Diagnostic specificity of breath test combined with computed tomography
Time frame: 8 weeks
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
Diagnostic accuracy of breath test combined with computed tomography
Time frame: 8 weeks
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic accuracy of breath test combined with computed tomography will be calculated
2 secondary outcomes
Positive predictive value of breath test combined with computed tomography
Time frame: 8 weeks
Negative predictive value of breath test combined with computed tomography
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Peiyu Wang, MM contact
Mantang Qiu, PhD principal investigator
Peking University People's Hospital
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 Non-small Cell Lung Cancer and Pulmonary Nodule, Multiple, run by Peking University People's Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mantang Qiu, PhD (13915973485, qiumantang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity of breath test combined with computed tomography (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2022.