Lung NeoplasmVOCsNCT02965300
The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis
An observational study of Lung Neoplasm and Lung Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath of pulmonary lesion patients and healthy controls, in order to find the difference of composition and concentration among groups. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasm, Lung Disease
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Aug 2017
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with lung disease or healthy controls without lung diseases， and can cooperate with the collection of exhaled breath.
Who may be able to join
- cohort 1 :
- Patients newly diagnosed with primary lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy.
- Age ≥ 18 years
- cohort 2： Inclusion criteria： Patients diagnosed with pulmonary benign lesion by tissue biopsy or other examination.
- Age ≥ 18 years
Who cannot join
- patients who have more than one type of carcinoma patients diagnosed type 2 diabetes mellitus patients diagnosed chronic renal failure patients diagnosed upper digestive tract ulcer patients who reject to sign the informed consent from
- cohort 3： Healthy controls Volunteers without diagnosed lung diseases and pulmonary symptoms.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of respiratory department ,Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Liang-an Chen, MD,PHD, 8610-55499027, cla301@126.com
Liang-an Chen, MD,PHD
About this study
The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath of pulmonary lesion patients and healthy controls, in order to find the difference of composition and concentration among groups.
Read the detailed description
Collect the exhaled gas in pulmonary lesion patients and healthy controls, using proton transfer reaction mass spectrometry to analysis the different composition and concentration of VOCs, to find the biomarker gases of distinguishing benign and malignant lesion of lung among different groups， and try to build a diagnostic model for lung lesion.
- Conditions
- Lung Neoplasm, Lung Disease
- Keywords
- Pulmonary lesion, Volatile Organic Compositions(VOCs)
- Medical subject headings
- Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary lung cancer | patients newly diagnosed with lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy. | |
| Benign lung lesion | Patients diagnosed with pulmonary benign diseases. | |
| Healthy control | Patients without any pulmonary abnormal symptoms or diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass-to-charge Ratio
It is the measurement result of VOCs in exhaled breath using PTR-MS device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- liang-an Chen, MD,PHD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965300
- Sponsor's protocol ID
- S2016-110-01
- Acronym
- VOCs
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: considering of personal privacy, the research-related individual participant data do not intend for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis
- ClinicalTrials.gov ID
- NCT02965300
- Acronym / sponsor ID
- VOCs / S2016-110-01
- Conditions
- Lung Neoplasm, Lung Disease
- Keywords
- Pulmonary lesion, Volatile Organic Compositions(VOCs)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- 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.
The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath of pulmonary lesion patients and healthy controls, in order to find the difference of composition and concentration among groups.
Detailed description
Collect the exhaled gas in pulmonary lesion patients and healthy controls, using proton transfer reaction mass spectrometry to analysis the different composition and concentration of VOCs, to find the biomarker gases of distinguishing benign and malignant lesion of lung among different groups， and try to build a diagnostic model for lung lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary lung cancer | – | –patients newly diagnosed with lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy. |
| Benign lung lesion | – | –Patients diagnosed with pulmonary benign diseases. |
| Healthy control | – | –Patients without any pulmonary abnormal symptoms or diseases |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lung disease or healthy controls without lung diseases， and can cooperate with the collection of exhaled breath.
Key inclusion criteria (5 listed)
- cohort 1 :
- Patients newly diagnosed with primary lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy.
- Age ≥ 18 years
- cohort 2： Inclusion criteria： Patients diagnosed with pulmonary benign lesion by tissue biopsy or other examination.
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- patients who have more than one type of carcinoma patients diagnosed type 2 diabetes mellitus patients diagnosed chronic renal failure patients diagnosed upper digestive tract ulcer patients who reject to sign the informed consent from
- cohort 3： Healthy controls Volunteers without diagnosed lung diseases and pulmonary symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mass-to-charge Ratio
Time frame: 6 months
It is the measurement result of VOCs in exhaled breath using PTR-MS device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Individual participant dataSharing planned: No. considering of personal privacy, the research-related individual participant data do not intend for public sharing.
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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.
liang-an Chen, MD,PHD principal investigator
Chinese PLA General 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 Lung Neoplasm and Lung Disease, run by Chinese PLA General 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 5 inclusion and 2 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 16 Nov 2016. 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 Liang-an Chen, MD,PHD (8610-55499027, cla301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass-to-charge Ratio (time frame: 6 months). 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 16 Nov 2016.