CarcinomaNCT04419207
Detecting Lung Cancer Based on Exhaled Breath
An observational study of Carcinoma and Lung Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Lung Cancer, NSCLC
- What is being tested?
- Breath test
- How many people
- 2,236 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible inpatients will be recruited from Department of Thoracic Surgery, Peking University People's Hospital and Beijing Haidian Hospital. For healthy controls, eligible participants will be recruited from those who receive planned annual physical examination at Aerospace 731 Hospital.
Who may be able to join
- pulmonary nodules in competed tomography images
- plan to receive thoracic surgery
- have planned physical examination every year
- plan to receive low-dose computed tomography
Who cannot join
- history of malignant tumors.
- receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery
- with infections or liver disease
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Detecting Lung Cancer by Volatile Organic Compounds in Exhaled Breath: a Study of Lung Cancer Diagnostic Biomarker
Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.
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.
In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.
- Conditions
- Carcinoma, Lung Cancer, NSCLC, Lung Neoplasms
- Being tested
- Breath test
- Keywords
- volatile organic compounds, exhaled breath, biomarker
- Medical subject headings
- Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Surbery | Patients who with pulmonary nodules in computed tomography and planned to receive thoracic surgery will be included. And those who have other types of cancer, received anti-tumor treatment before surgery, liver disease, or infections will be excluded. Receives: Diagnostic Test: Breath test | |
| Healthy Controls | Adult participants (>18 yr) who plan to receive annual physical examination and low-dose computed tomography will be included. And those who have history cancers, received anti-tumor treatment before surgery, liver disease, or infections will be excluded. Receives: Diagnostic Test: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity of exhaled breath
Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated
Measured: 2 year
Diagnostic specificity of exhaled breath
Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated
Measured: 2 year
Positive predictive value of exhaled breath
Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated
Measured: 2 year
Negative predictive value of exhaled breath
Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated
Measured: 2 year
Diagnostic accuracy of exhaled breath
Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- 2,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital, Aerospace 731 Hospital, Beijing Breatha Biological Technology Co., Ltd, Beijing, The First Affiliated Hospital of Zhengzhou University, Jiangsu Cancer Institute & Hospital
- Responsible party
- Principal investigator, zhouzuli, Peking University People's Hospital
- Investigators
- Mantang Qiu, M.D, Study chair, Peking University People's Hospital Thoracic Surgery DepartmentZuli Zhou, M.D, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419207
- Sponsor's protocol ID
- 2019PHB095-01
- Status last verified
- Apr 2022
- First submitted
- 4 Jun 2020
- 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
- Detecting Lung Cancer by Volatile Organic Compounds in Exhaled Breath: a Study of Lung Cancer Diagnostic Biomarker
- ClinicalTrials.gov ID
- NCT04419207
- Acronym / sponsor ID
- 2019PHB095-01
- Conditions
- Carcinoma, Lung Cancer, NSCLC, Lung Neoplasms
- Keywords
- volatile organic compounds, exhaled breath, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,236 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital, Aerospace 731 Hospital, Beijing Breatha Biological Technology Co., Ltd, Beijing, The First Affiliated Hospital of Zhengzhou University, Jiangsu Cancer Institute & Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 5 Jun 2020 (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.
Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.
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.
In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Surbery | – | Diagnostic Test: Breath testPatients who with pulmonary nodules in computed tomography and planned to receive thoracic surgery will be included. And those who have other types of cancer, received anti-tumor treatment before surgery, liver disease, or infections will be excluded. |
| Healthy Controls | – | Diagnostic Test: Breath testAdult participants (>18 yr) who plan to receive annual physical examination and low-dose computed tomography will be included. And those who have history cancers, received anti-tumor treatment before surgery, liver disease, or infections will be excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible inpatients will be recruited from Department of Thoracic Surgery, Peking University People's Hospital and Beijing Haidian Hospital. For healthy controls, eligible participants will be recruited from those who receive planned annual physical examination at Aerospace 731 Hospital.
Key inclusion criteria (4 listed)
- pulmonary nodules in competed tomography images
- plan to receive thoracic surgery
- have planned physical examination every year
- plan to receive low-dose computed tomography
Key exclusion criteria (3 listed)
- history of malignant tumors.
- receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery
- with infections or liver disease
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 |
|---|---|---|
| Breath testExhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS). | Diagnostic test | Healthy Controls, Patients with Surbery |
Primary outcome
Diagnostic sensitivity of exhaled breath
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated
Diagnostic specificity of exhaled breath
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated
Positive predictive value of exhaled breath
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated
Negative predictive value of exhaled breath
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated
Diagnostic accuracy of exhaled breath
Time frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated
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 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.
Mantang Qiu, M.D study chair
Peking University People's Hospital Thoracic Surgery Department
Zuli Zhou, M.D 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 Carcinoma and Lung Cancer, 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 4 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 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?
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?
Diagnostic sensitivity of exhaled breath (time frame: 2 year). The study lists 5 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.