Lung CancerNCT04938804
Non-risk Based Lang Cancer Screening With a One-off LDCT
A study testing Low-dose computed tomography in people with Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021.The primary outcome was LC detection rate in eligible participants without… Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low-dose computed tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2015to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Minimum age of 40 years among the residents in Guangzhou
Who cannot join
- Persons who had a diagnosis or treatment related to LC within the past 5 years, had undergone chest CT within the past year, or had significant cancer-related symptoms (e.g., hemoptysis, dyspnea, inability to climb two flights of stairs).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Wenhua Liang, MD, +86-02-83062808, liangwh1987@163.com
About this study
Official title: Non-risk Based Lung Cancer Screening With One-time Low-dose Computed Tomography: a Prospective Cohort Study
Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021.The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC.
Read the detailed description
Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021. Follow-up for post-screening management and survival was recorded. The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC. Additionally, we compared the detection rates of LC and the proportion of stage I LC cases between "high-risk" and "non-high-risk" groups according to the National Comprehensive Cancer Network (NCCN) guidelines and Chinese guideline.
- Conditions
- Lung Cancer
- Being tested
- Low-dose computed tomography
- Keywords
- Screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomographyDevice
The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.
| Study group | Role | What they receive |
|---|---|---|
| Screening group | Experimental | Not described Receives: Device: Low-dose computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of lung cancer
Lung cancer detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases.
Measured: 11 years
To investigate the various factors associated with the development of lung cancer
To investigate the various factors associated with the development of lung cancer
Measured: 11 years
Secondary outcomes (2)
Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups
The detection rate of lung cancer among people with "high-risk" and "non-high-risk"factors
Measured: 11 years
Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start12 Dec 2015
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Wenhua Liang, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938804
- Sponsor's protocol ID
- GZLUNG
- Status last verified
- Jan 2024
- First submitted
- 12 Jun 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ye W, Fu W, Li C, Li J, Xiong S, Cheng B, Xu B, Wang Q, Feng Y, Chen P, He J, Liang W. Diameter thresholds for pure ground-glass pulmonary nodules at low-dose CT screening: Chinese experience. Thorax. 2025 Jan 17;80(2):76-85. doi: 10.1136/thorax-2024-221642.
PubMed 39689940
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-risk Based Lung Cancer Screening With One-time Low-dose Computed Tomography: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04938804
- Acronym / sponsor ID
- GZLUNG
- Conditions
- Lung Cancer
- Keywords
- Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 12 Dec 2015 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Jun 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.
Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021.The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC.
Detailed description
Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021. Follow-up for post-screening management and survival was recorded. The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC. Additionally, we compared the detection rates of LC and the proportion of stage I LC cases between "high-risk" and "non-high-risk" groups according to the National Comprehensive Cancer Network (NCCN) guidelines and Chinese guideline.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening group | Experimental | Device: Low-dose computed tomography |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Minimum age of 40 years among the residents in Guangzhou
Key exclusion criteria (1 listed)
- Persons who had a diagnosis or treatment related to LC within the past 5 years, had undergone chest CT within the past year, or had significant cancer-related symptoms (e.g., hemoptysis, dyspnea, inability to climb two flights of stairs).
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 computed tomographyThe Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology. | Device | Screening group |
Primary outcome
The detection rate of lung cancer
Time frame: 11 years
Lung cancer detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases.
To investigate the various factors associated with the development of lung cancer
Time frame: 11 years
To investigate the various factors associated with the development of lung cancer
2 secondary outcomes
Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups
Time frame: 11 years
Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)
Time frame: 11 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 39689940Ye W, Fu W, Li C, Li J, Xiong S, Cheng B, Xu B, Wang Q, Feng Y, Chen P, He J, Liang W. Diameter thresholds for pure ground-glass pulmonary nodules at low-dose CT screening: Chinese experience. Thorax. 2025 Jan 17;80(2):76-85. doi: 10.1136/thorax-2024-221642.
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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.
Wenhua Liang, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 computed tomography in people with Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University 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 1 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: looking for participants now, as of the sponsor's last update on 9 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhua Liang, MD (+86-02-83062808, liangwh1987@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of lung cancer (time frame: 11 years). The study lists 2 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 NCT04938804, 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 9 Jan 2024.