Lung NeoplasmsNCT03988322
Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai, China
A study testing Low-dose CT screening with quantitative assessment and management of imaging biomarkers and Low-dose CT screening with visual assessment and management of imaging biomarkers in people with Lung Neoplasms and Mass Screening, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms, Mass Screening, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Low-dose CT screening with quantitative assessment and management of imaging biomarkers and Low-dose CT screening with visual assessment and management of imaging biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to Sep 2022
- Phase
- Interventional
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- asymptomatic (without complaints of chest discomfort) residents registered in Shanghai city.
- age between 40-74 years old
- no history of lung cancer (self-reported).
Who cannot join
- Pregnant women will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai
Shiyuan Liu, Prof, 021-81886609, cjr.liushiyuan@vip.163.com
About this study
Official title: Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: a Population-based Comparative Study
Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Studies in European population showed the benefit of volumetric assessment of CT screening-detected lung nodules compared to diameter-based assessment. Screening for COPD and CVD, in addition to lung cancer, may significantly increase the benefits of low-dose CT lung cancer screening. The objective is to assess the screening performance of volume-based management of CT-detected lung nodule in comparison to diameter-based management, and to improve the effectiveness of CT screening for COPD and CVD, in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. Thus, a population-based comparative study will be performed in Shanghai, China.
Read the detailed description
The study will recruit 10,000 asymptomatic participants between 40 and 74 years old from Shanghai urban population. The 5000 participants in the intervention group will undergo a low-dose CT scan at baseline and one year later, and will be managed according to European volume-based protocol. The 5000 participants in the control group will undergo a low-dose CT scan according to the routine CT protocol and will be managed according to the clinical practice. Epidemiological data will be collected through questionnaires. In the fourth year from baseline, the diagnosis of the three diseases will be collected. The screening performance will be compared between volume-based and standard protocol for managing early-detected lung nodules. The effectiveness of quantitative measurement of CT imaging biomarkers for early detection of lung cancer, COPD and CVD will be evaluated.
The detected lung nodules in the intervention group will be classified into three groups depending on nodule volume: < 100 mm3 (negative result), 100-300 mm3 (indeterminate result) and > 300 mm3 (positive result). In case of a negative result, a CT scan after one year is recommended. In case of an indeterminate result, a 3-month follow up CT is recommended at which VDT will be assessed. For short VDT (< 400 days), the screening result is positive. Long VDT (> 400 days) is considered a negative screening result. In case of a positive result, referral to a multidisciplinary team is recommended for further investigation. The detected nodules in the control group will be managed according to the recommended cut-off values of diameter from NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening.
- Conditions
- Lung Neoplasms, Mass Screening, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease
- Being tested
- Low-dose CT screening with quantitative assessment and management of imaging biomarkers, Low-dose CT screening with visual assessment and management of imaging biomarkers
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CT screening with quantitative assessment and management of imaging biomarkersOther
Participants will be screened with a low-dose CT (a Philips 256-slice CT system). The CT images will be obtain according to the pre-defined CT scan protocol. This CT protocol is developed for quantitative assessment of lung nodules, COPD and coronary artery calcium. Detected lung nodules will be managed according to the European volume-based protocol, based on the volume and volume doubling time of lung nodule. COPD will be management according to the result of lung function test. The imaging biomarkers (eg., emphysema index, airway wall thickness, and coronary artery calcium ) will be quantitatively registered. In addition, a number of participants' characteristics will be collected: physical examination (weight, height, blood pressure), laboratory measurements (eg., fasting plasma glucose, total cholesterol, HDL-cholesterol). The social-demographic characteristics, risk factors of the 3 diseases, and health status of the participants will be collected through questionnaires.
Low-dose CT screening with visual assessment and management of imaging biomarkersOther
Participants will be screened with a low-dose CT (a Philips 64 MDCT system). The CT images will be obtain according to the routine CT scan protocol for lung cancer screening in the hospital. Detected lung nodules will be managed according to the diameter of the nodule based on the NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening. Detected emphysema and/or bronchial wall thickness, coronary artery calcium will be qualitatively recorded (yes/no).
| Study group | Role | What they receive |
|---|---|---|
| Quantitative assessment of imaging biomarkers | Experimental | This is the intervention arm. In this arm, the participants will be scanned with low-dose CT with pre-defined scanning parameters for two rounds (at baseline and in the second year). The screen-detected lung nodules will be managed according to the volume of the nodule. The quantitative assessment of imaging biomarkers of lung cancer, COPD and cardiovascular disease will be recorded. Receives: Other: Low-dose CT screening with quantitative assessment and management of imaging biomarkers |
| Visual assessment of imaging biomarkers | Active comparator | This is the control arm. In this arm, the participants will be scanned with low-dose CT with routine scanning parameters used for lung cancer screening in the hospital for two rounds (at baseline and in the second year). The screen-detected lung nodules will be managed according to the diameter of the nodule. The imaging biomarkers related to lung cancer, COPD and cardiovascular disease will be visually assessed. Receives: Other: Low-dose CT screening with visual assessment and management of imaging biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of incident lung cancer
The number of clinically diagnosed lung cancer will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
Measured: at the fourth year from baseline
number of COPD
The number of clinically diagnosed COPD, the number of hospitalization due to COPD and the number of acute exacerbation will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
Measured: at the fourth year from baseline
number of cardiovascular event
The number of cardiovascular event(eg, major adverse cardiovascular event, myocardial infarction, stroke)will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
Measured: at the fourth year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Sep 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu ShiYuan, Shanghai Changzheng Hospital
- Investigators
- Shiyuan Liu, Prof, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988322
- Sponsor's protocol ID
- 2016YFE0103000
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and publications of study results will be shared.
Publications
Du Y, Li Q, Sidorenkov G, Vonder M, Cai J, de Bock GH, Guan Y, Xia Y, Zhou X, Zhang D, Rook M, Vliegenthart R, Heuvelmans MA, Dorrius MD, van Ooijen PMA, Groen HJM, van der Harst P, Xiao Y, Ye Z, Xie X, Wang W, Oudkerk M, Fan L, Liu S. Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: Rationale and Design of a Population-based Comparative Study. Acad Radiol. 2021 Jan;28(1):36-45. doi: 10.1016/j.acra.2020.01.020. Epub 2020 Mar 6.
PubMed 32151538
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: a Population-based Comparative Study
- ClinicalTrials.gov ID
- NCT03988322
- Acronym / sponsor ID
- 2016YFE0103000
- Conditions
- Lung Neoplasms, Mass Screening, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Jun 2019 (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.
Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Studies in European population showed the benefit of volumetric assessment of CT screening-detected lung nodules compared to diameter-based assessment. Screening for COPD and CVD, in addition to lung cancer, may significantly increase the benefits of low-dose CT lung cancer screening. The objective is to assess the screening performance of volume-based management of CT-detected lung nodule in comparison to diameter-based management, and to improve the effectiveness of CT screening for COPD and CVD, in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. Thus, a population-based comparative study will be performed in Shanghai, China.
Detailed description
The study will recruit 10,000 asymptomatic participants between 40 and 74 years old from Shanghai urban population. The 5000 participants in the intervention group will undergo a low-dose CT scan at baseline and one year later, and will be managed according to European volume-based protocol. The 5000 participants in the control group will undergo a low-dose CT scan according to the routine CT protocol and will be managed according to the clinical practice. Epidemiological data will be collected through questionnaires. In the fourth year from baseline, the diagnosis of the three diseases will be collected. The screening performance will be compared between volume-based and standard protocol for managing early-detected lung nodules. The effectiveness of quantitative measurement of CT imaging biomarkers for early detection of lung cancer, COPD and CVD will be evaluated.
The detected lung nodules in the intervention group will be classified into three groups depending on nodule volume: < 100 mm3 (negative result), 100-300 mm3 (indeterminate result) and > 300 mm3 (positive result). In case of a negative result, a CT scan after one year is recommended. In case of an indeterminate result, a 3-month follow up CT is recommended at which VDT will be assessed. For short VDT (< 400 days), the screening result is positive. Long VDT (> 400 days) is considered a negative screening result. In case of a positive result, referral to a multidisciplinary team is recommended for further investigation. The detected nodules in the control group will be managed according to the recommended cut-off values of diameter from NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantitative assessment of imaging biomarkers | Experimental | Other: Low-dose CT screening with quantitative assessment and management of imaging biomarkersThis is the intervention arm. In this arm, the participants will be scanned with low-dose CT with pre-defined scanning parameters for two rounds (at baseline and in the second year). The screen-detected lung nodules will be managed according to the volume of the nodule. The quantitative assessment of imaging biomarkers of lung cancer, COPD and cardiovascular disease will be recorded. |
| Visual assessment of imaging biomarkers | Active comparator | Other: Low-dose CT screening with visual assessment and management of imaging biomarkersThis is the control arm. In this arm, the participants will be scanned with low-dose CT with routine scanning parameters used for lung cancer screening in the hospital for two rounds (at baseline and in the second year). The screen-detected lung nodules will be managed according to the diameter of the nodule. The imaging biomarkers related to lung cancer, COPD and cardiovascular disease will be visually assessed. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- asymptomatic (without complaints of chest discomfort) residents registered in Shanghai city.
- age between 40-74 years old
- no history of lung cancer (self-reported).
Key exclusion criteria (1 listed)
- Pregnant women will be excluded.
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 |
|---|---|---|
| Low-dose CT screening with quantitative assessment and management of imaging biomarkersParticipants will be screened with a low-dose CT (a Philips 256-slice CT system). The CT images will be obtain according to the pre-defined CT scan protocol. This CT protocol is developed for quantitative assessment of lung nodules, COPD and coronary artery calcium. Detected lung nodules will be managed according to the European volume-based protocol, based on the volume and volume doubling time of lung nodule. COPD will be management according to the result of lung function test. The imaging biomarkers (eg., emphysema index, airway wall thickness, and coronary artery calcium ) will be quantitatively registered. In addition, a number of participants' characteristics will be collected: physical examination (weight, height, blood pressure), laboratory measurements (eg., fasting plasma glucose, total cholesterol, HDL-cholesterol). The social-demographic characteristics, risk factors of the 3 diseases, and health status of the participants will be collected through questionnaires. | Other | Quantitative assessment of imaging biomarkers |
| Low-dose CT screening with visual assessment and management of imaging biomarkersParticipants will be screened with a low-dose CT (a Philips 64 MDCT system). The CT images will be obtain according to the routine CT scan protocol for lung cancer screening in the hospital. Detected lung nodules will be managed according to the diameter of the nodule based on the NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening. Detected emphysema and/or bronchial wall thickness, coronary artery calcium will be qualitatively recorded (yes/no). | Other | Visual assessment of imaging biomarkers |
Primary outcome
number of incident lung cancer
Time frame: at the fourth year from baseline
The number of clinically diagnosed lung cancer will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
number of COPD
Time frame: at the fourth year from baseline
The number of clinically diagnosed COPD, the number of hospitalization due to COPD and the number of acute exacerbation will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
number of cardiovascular event
Time frame: at the fourth year from baseline
The number of cardiovascular event(eg, major adverse cardiovascular event, myocardial infarction, stroke)will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Derived from this study: PubMed 32151538Du Y, Li Q, Sidorenkov G, Vonder M, Cai J, de Bock GH, Guan Y, Xia Y, Zhou X, Zhang D, Rook M, Vliegenthart R, Heuvelmans MA, Dorrius MD, van Ooijen PMA, Groen HJM, van der Harst P, Xiao Y, Ye Z, Xie X, Wang W, Oudkerk M, Fan L, Liu S. Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: Rationale and Design of a Population-based Comparative Study. Acad Radiol. 2021 Jan;28(1):36-45. doi: 10.1016/j.acra.2020.01.020. Epub 2020 Mar 6.
- Individual participant dataSharing planned: Yes. The study protocol and publications of study results will be shared.
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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.
Shiyuan Liu, Prof principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose CT screening with quantitative assessment and management of imaging biomarkers and Low-dose CT screening with visual assessment and management of imaging biomarkers in people with Lung Neoplasms and Mass Screening, run by Shanghai Changzheng 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 1 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 17 Jun 2019. 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 Shiyuan Liu, Prof (021-81886609, cjr.liushiyuan@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of incident lung cancer (time frame: at the fourth year from baseline). 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?
On the ClinicalTrials.gov record for NCT03988322, 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 17 Jun 2019.