Lung CancerNCT05494021
China Lung Cancer Screening (CLUS) Study Version 3.0
A study testing Whole-process management software and LDCT detection in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Whole-process management software and LDCT detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants were those aged 45-75 years, and with either of the following risk factors:
- history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
- malignant tumors history in immediate family members;
- personal cancer history;
- professional exposure to carcinogens;
- long term exposure to second-hand smoke;
- long term exposure to cooking oil fumes.
Who cannot join
- Had a CT scan of chest within last 12 months
- History of any cancer within 5 years
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
Shanghai Chest hospital
Shanghai, Shanghai Municipality, 200030
Baohui Han, Doctor, 8618930858216, 18930858216@163.com
Yanwei Zhang, Doctor, +8615216687683, zhangywshxkyy@163.com
About this study
Official title: Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0
CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.
- Conditions
- Lung Cancer
- Being tested
- Whole-process management software, LDCT detection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-process management softwareOther
Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
LDCT detectionDevice
LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
| Study group | Role | What they receive |
|---|---|---|
| Whole-process management strategy | Experimental | High-risk individuls are provided with whole-process management strategy, including lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
LDCT was performed at baseline + 2 biennial repeated LDCT rounds. Receives: Other: Whole-process management software; Device: LDCT detection |
| Rountine screening strategy | Active comparator | LDCT was performed at baseline + 2 biennial repeated LDCT rounds. Receives: Device: LDCT detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mortality rate of lung cancer
Assess lung cancer mortality within next 5 years after first round of screening
Measured: 5 years
The attendance rate of high-risk individuals
Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals
Measured: 5 years
The adherence rate of high-risk individuals
Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals
Measured: 5 years
Secondary outcomes (3)
The mortality of all-cause
Assess all-cause mortality within next 5 years after first round of screening
Measured: 5 years
The detection rate of lung nodules
Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening
Measured: 5 years
The incidence rate lung cancer
Assess the number of lung cancer incidences after each round of screening
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Shanghai Chest 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baohui Han, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494021
- Sponsor's protocol ID
- CLUS 3.0
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0
- ClinicalTrials.gov ID
- NCT05494021
- Acronym / sponsor ID
- CLUS 3.0
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2022 (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.
CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-process management strategy | Experimental | Other: Whole-process management software, Device: LDCT detectionHigh-risk individuls are provided with whole-process management strategy, including lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer. LDCT was performed at baseline + 2 biennial repeated LDCT rounds. |
| Rountine screening strategy | Active comparator | Device: LDCT detectionLDCT was performed at baseline + 2 biennial repeated LDCT rounds. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible participants were those aged 45-75 years, and with either of the following risk factors:
Key exclusion criteria (2 listed)
- Had a CT scan of chest within last 12 months
- History of any cancer within 5 years
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 |
|---|---|---|
| Whole-process management softwareEnrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer. | Other | Whole-process management strategy |
| LDCT detectionLDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm | Device | Rountine screening strategy, Whole-process management strategy |
Primary outcome
The mortality rate of lung cancer
Time frame: 5 years
Assess lung cancer mortality within next 5 years after first round of screening
The attendance rate of high-risk individuals
Time frame: 5 years
Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals
The adherence rate of high-risk individuals
Time frame: 5 years
Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals
3 secondary outcomes
The mortality of all-cause
Time frame: 5 years
The detection rate of lung nodules
Time frame: 5 years
The incidence rate lung cancer
Time frame: 5 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 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-process management software and LDCT detection in people with Lung Cancer, run by Shanghai Chest 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 7 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: looking for participants now, as of the sponsor's last update on 9 Aug 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mortality rate of lung cancer (time frame: 5 years). 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?
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 Aug 2022.