Lung CancerNCT07478757
Assessing the Effectiveness of Low-Dose Computed Tomography in Lung Cancer Screening for High-Risk Smokers: A Randomized Controlled Trial in Hong Kong
A study testing Low-dose computed tomography (LDCT) in people with Lung Cancer and Lung Cancer Screening, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators propose a randomized controlled trial to evaluate the clinical effectiveness of low-dose computed tomography (LDCT) for lung cancer screening in high-risk Chinese ever-smokers aged 50-79 years in Hong Kong and to assess the cost-effectiveness of implementing LDCT for lung cancer screening in the… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Lung Cancer Screening
- What is being tested?
- Low-dose computed tomography (LDCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2026to 30 Jun 2037
- 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 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 50 and 79 years
- Current smokers or ex-smokers quitted for less than 10 years, with a history of cigarette smoking equivalent to at least 20 pack-years
Who cannot join
- Non-Chinese population
- Individuals who are not mentally competent to provide informed consent (e.g., those with a history of dementia)
- Individuals with a known prior diagnosis of lung cancer or detection of lung nodules
- Individuals with a history of other cancers within the last five years or currently under treatment
- Individuals who have undergone a CT scan of the thorax in the previous 12 months
- Individuals who are either unwilling to undergo a chest LDCT scan, or having a condition that prevents them from having a LDCT scan (for example, pregnancy or inability to lie flat on the CT table)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
School of Public Health, The University of Hong Kong
Hong Kong
About this study
The investigators propose a randomized controlled trial to evaluate the clinical effectiveness of low-dose computed tomography (LDCT) for lung cancer screening in high-risk Chinese ever-smokers aged 50-79 years in Hong Kong and to assess the cost-effectiveness of implementing LDCT for lung cancer screening in the local setting.
Read the detailed description
Background:
Lung cancer is an important public health problem in Hong Kong and worldwide. In Hong Kong, lung cancer always ranked the top in terms of incidence and mortality among common cancers in both sexes. Previous studies has suggested that cancer screening could potentially achieve a stage shift that enables the diagnosis of more cancer cases in early-stages (I or II), thereby enabling earlier treatment of early-stage cancers rather than advanced-stage cancers to achieve higher survival rates and reduction in the overall mortality. In particular, low-dose computed tomography (LDCT) was reported to be effective in screening for lung cancer among smokers in some countries. However, given the vast difference in smoking prevalence, lung cancer incidence and staging pattern at presentation, findings regarding both benefits and harms from one population may not be directly applicable to other populations. This highlights the importance of local evidence on both clinical effectiveness and cost-effectiveness of LDCT lung cancer screening in Hong Kong.
Aim:
To implement LDCT screening for high-risk ever-smokers to generate local data and robust evidence on the clinical effectiveness, cost-effectiveness, and feasibility of LDCT screening.
Study Design and overview:
This study will adopt the design of a randomized controlled trial. A total of 15,000 high-risk Chinese ever-smokers, aged 50-79 years with a smoking history of at least 20 pack-years in Hong Kong will be recruited. We target both current smokers, and former smokers who had quitted within the past 10 years. All participants are targeted to be recruited in the first year of the study, and to be followed-up for a total of 10 years; including regular active follow-up in the initial five years followed by an interim analysis to be conducted by the end of that period, and continuous outcome ascertainment by data matching in the next five years before the final analysis. After the baseline recruitment visit (T0), all enrolled participants will be randomized with a 1:1 ratio into either the screening arm (n = 7,500) with 3 LDCT screening to be done during the study period, or the control arm (n = 7,500) with no screening provided. All participants will be followed-up at 18 ± 3 months (T1), 42 ± 3 months (T2), and at 60 months (T3) from baseline. The three rounds of LDCT screening for participants in the screening arm will be performed at T0, T1, and T2. Participants in both arms will have free blood tests at T0, T1, and T2, with complete blood count (CBC), lipid function, and basic renal and liver function test (RFT/LFT) to be tested at different designated time points. All participants, in both the screening or control arm will be referred to smoking cessation services provided by the participating non-government organizations (NGOs) upon randomization.
Participants' consents for accessing their updated health status data from various sources will be obtained. Data on lung cancer incidence and mortality of participants will be continuously ascertained on follow-up contact. Cancer-related details including stage on diagnosis, laboratory test results, treatments including medication offered and procedures performed will be collected every 6 months through an agreement to be worked out with the Data Sharing Portal services of the Hospital Authority (HA), to be supplemented by clarification through HA's Clinical Management System (CMS) if needed. The survival status of participants will be continuously updated on follow-up contact, and to be checked though the Deaths Registry if needed, for up to 10 years since randomization on a half-yearly basis.
Interventions:
SCREEN arm: 3 LDCT screening services will be provided. CONTROL arm: No LDCT screening service will be provided.
Study Endpoints and outcome measures:
The primary endpoint of this study is lung cancer mortality. Secondary endpoints includes (i) stage distribution of lung cancer cases; (ii) lung cancer incidence; (iii) prevalence of false-positive of screening cases; (iv) percentage of overdiagnosis of lung cancer cases; (v) prevalence of radiation-induced cancers; and (vi) health-related quality of life (HRQoL).
Main analysis:
Intention-to-screen (ITS) approach.
Potential significance:
The findings will help to inform evidence-based recommendations for the consideration of lung cancer screening in Hong Kong's healthcare system.
- Conditions
- Lung Cancer, Lung Cancer Screening
- Being tested
- Low-dose computed tomography (LDCT)
- Keywords
- Lung Cancer, Low-dose computed tomography (LDCT), Screening, High-risk smokers
- 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 tomography (LDCT)Diagnostic test
3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline
| Study group | Role | What they receive |
|---|---|---|
| SCREEN Arm | Active comparator | SCREEN Arm: 3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline Receives: Diagnostic Test: Low-dose computed tomography (LDCT) |
| CONTROL arm | No intervention | CONTROL arm: No LDCT screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer mortality
Defined as the lung cancer-related death. The survival status of diagnosed lung cancer patients in both arms will be reviewed yearly after the first five years up to 10 years through Hospital Authority of Hong Kong (HA)'s Data Sharing Portal services or the Deaths Registry, supplemented by access to Clinical Management System (CMS) if needed. The lung cancer mortality rate will be calculated by dividing (a) the number of lung cancer-related deaths by (b) the number of person-years.
Measured: 10 years
Secondary outcomes (6)
Stage distribution of lung cancer cases
Defined as the stage distribution of lung cancer cases in both arms. The number of lung cancer cases of diagnosed cancer stages, namely, stages 1, 2, 3, and 4, as well as unstaged, will be recorded.
Measured: 10 years
Lung cancer incidence
Long-term lung cancer-related data will be extracted through electronic medical record systems to evaluate the changes in lung cancer incidence rate in both arms. Data on lung cancer incidence related details and the survival status will be reviewed yearly up to 10 years through the Hospital Authority of Hong Kong (HA)'s Data Sharing Portal and the Deaths Registry, and to be supplemented by access to Clinical Management System (CMS) at HA for clarification and checking of specific issues if needed.
Measured: 10 years
Prevalence of false-positive of screening cases
A false positive screen refers to a positive screen that no lung cancer is diagnosed after undergoing further confirmatory diagnostic workup. The prevalence of false-positive of screening cases is calculated as dividing (a) the number of false positive screenings by (b) the total number of scans performed.
Measured: 10 years
Percentage of overdiagnosis of lung cancer cases
Overdiagnosis refers to a screen-detected lung cancer case that would not be diagnosed if screening is not performed. The overdiagnosis percentage in all diagnosed lung cancer cases in the screening arm is calculated as dividing (a) the difference between the rate of lung cancer detected in the screening arm and the control arm by (b) the rate of lung cancer detected in the screening arm.
Measured: 10 years
Prevalence of radiation-induced cancers
The potential impact of additional radiation exposure to the development of cancers at sites other than the lung among participants in the screening arm will be assessed.
Measured: 10 years
Health-related quality of life (HRQoL)
A HRQoL assessment based on the EQ-5D instrument will be completed by all participants in both arms at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2), and 60 months (T3) from baseline. The HRQoL score will be compared between participants in the screening arm and the control arm. The consideration of HRQoL enables quantifying the effects of early detection and early treatment on screen-detected cases in terms of the changes in survival time and health status.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Responsible party
- Principal investigator, Prof Dennis Kai-Ming Ip, The University of Hong Kong
- Investigators
- Dennis KM Ip, MD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478757
- Sponsor's protocol ID
- HKU-HKLCS.1
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Low-Dose Computed Tomography in Lung Cancer Screening for High-Risk Smokers: A Randomized Controlled Trial in Hong Kong
- ClinicalTrials.gov ID
- NCT07478757
- Acronym / sponsor ID
- HKU-HKLCS.1
- Conditions
- Lung Cancer, Lung Cancer Screening
- Keywords
- Lung Cancer, Low-dose computed tomography (LDCT), Screening, High-risk smokers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2037 (estimated)
- First posted
- 17 Mar 2026 (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.
The investigators propose a randomized controlled trial to evaluate the clinical effectiveness of low-dose computed tomography (LDCT) for lung cancer screening in high-risk Chinese ever-smokers aged 50-79 years in Hong Kong and to assess the cost-effectiveness of implementing LDCT for lung cancer screening in the local setting.
Detailed description
Background:
Lung cancer is an important public health problem in Hong Kong and worldwide. In Hong Kong, lung cancer always ranked the top in terms of incidence and mortality among common cancers in both sexes. Previous studies has suggested that cancer screening could potentially achieve a stage shift that enables the diagnosis of more cancer cases in early-stages (I or II), thereby enabling earlier treatment of early-stage cancers rather than advanced-stage cancers to achieve higher survival rates and reduction in the overall mortality. In particular, low-dose computed tomography (LDCT) was reported to be effective in screening for lung cancer among smokers in some countries. However, given the vast difference in smoking prevalence, lung cancer incidence and staging pattern at presentation, findings regarding both benefits and harms from one population may not be directly applicable to other populations. This highlights the importance of local evidence on both clinical effectiveness and cost-effectiveness of LDCT lung cancer screening in Hong Kong.
Aim:
To implement LDCT screening for high-risk ever-smokers to generate local data and robust evidence on the clinical effectiveness, cost-effectiveness, and feasibility of LDCT screening.
Study Design and overview:
This study will adopt the design of a randomized controlled trial. A total of 15,000 high-risk Chinese ever-smokers, aged 50-79 years with a smoking history of at least 20 pack-years in Hong Kong will be recruited. We target both current smokers, and former smokers who had quitted within the past 10 years. All participants are targeted to be recruited in the first year of the study, and to be followed-up for a total of 10 years; including regular active follow-up in the initial five years followed by an interim analysis to be conducted by the end of that period, and continuous outcome ascertainment by data matching in the next five years before the final analysis. After the baseline recruitment visit (T0), all enrolled participants will be randomized with a 1:1 ratio into either the screening arm (n = 7,500) with 3 LDCT screening to be done during the study period, or the control arm (n = 7,500) with no screening provided. All participants will be followed-up at 18 ± 3 months (T1), 42 ± 3 months (T2), and at 60 months (T3) from baseline. The three rounds of LDCT screening for participants in the screening arm will be performed at T0, T1, and T2. Participants in both arms will have free blood tests at T0, T1, and T2, with complete blood count (CBC), lipid function, and basic renal and liver function test (RFT/LFT) to be tested at different designated time points. All participants, in both the screening or control arm will be referred to smoking cessation services provided by the participating non-government organizations (NGOs) upon randomization.
Participants' consents for accessing their updated health status data from various sources will be obtained. Data on lung cancer incidence and mortality of participants will be continuously ascertained on follow-up contact. Cancer-related details including stage on diagnosis, laboratory test results, treatments including medication offered and procedures performed will be collected every 6 months through an agreement to be worked out with the Data Sharing Portal services of the Hospital Authority (HA), to be supplemented by clarification through HA's Clinical Management System (CMS) if needed. The survival status of participants will be continuously updated on follow-up contact, and to be checked though the Deaths Registry if needed, for up to 10 years since randomization on a half-yearly basis.
Interventions:
SCREEN arm: 3 LDCT screening services will be provided. CONTROL arm: No LDCT screening service will be provided.
Study Endpoints and outcome measures:
The primary endpoint of this study is lung cancer mortality. Secondary endpoints includes (i) stage distribution of lung cancer cases; (ii) lung cancer incidence; (iii) prevalence of false-positive of screening cases; (iv) percentage of overdiagnosis of lung cancer cases; (v) prevalence of radiation-induced cancers; and (vi) health-related quality of life (HRQoL).
Main analysis:
Intention-to-screen (ITS) approach.
Potential significance:
The findings will help to inform evidence-based recommendations for the consideration of lung cancer screening in Hong Kong's healthcare system.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCREEN Arm | Active comparator | Diagnostic Test: Low-dose computed tomography (LDCT)SCREEN Arm: 3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline |
| CONTROL arm | No intervention | –CONTROL arm: No LDCT screening |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged between 50 and 79 years
- Current smokers or ex-smokers quitted for less than 10 years, with a history of cigarette smoking equivalent to at least 20 pack-years
Key exclusion criteria (6 listed)
- Non-Chinese population
- Individuals who are not mentally competent to provide informed consent (e.g., those with a history of dementia)
- Individuals with a known prior diagnosis of lung cancer or detection of lung nodules
- Individuals with a history of other cancers within the last five years or currently under treatment
- Individuals who have undergone a CT scan of the thorax in the previous 12 months
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 tomography (LDCT)3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline | Diagnostic test | SCREEN Arm |
Primary outcome
Lung cancer mortality
Time frame: 10 years
Defined as the lung cancer-related death. The survival status of diagnosed lung cancer patients in both arms will be reviewed yearly after the first five years up to 10 years through Hospital Authority of Hong Kong (HA)'s Data Sharing Portal services or the Deaths Registry, supplemented by access to Clinical Management System (CMS) if needed. The lung cancer mortality rate will be calculated by dividing (a) the number of lung cancer-related deaths by (b) the number of person-years.
6 secondary outcomes
Stage distribution of lung cancer cases
Time frame: 10 years
Lung cancer incidence
Time frame: 10 years
Prevalence of false-positive of screening cases
Time frame: 10 years
Percentage of overdiagnosis of lung cancer cases
Time frame: 10 years
Prevalence of radiation-induced cancers
Time frame: 10 years
Health-related quality of life (HRQoL)
Time frame: 10 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 17 Mar 2026.
- 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.
Dennis KM Ip, MD principal investigator
School of Public Health, The University of Hong Kong
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 (LDCT) in people with Lung Cancer and Lung Cancer Screening, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Mar 2026. 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 Hong Kong. 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 Teresa HC So ((+852) 39176714, haso9150@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer mortality (time frame: 10 years). 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 17 Mar 2026.