Lung Cancer ScreeningNCT07078032
A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
A study testing Prediction Model Arm and Standard Screening Arm in people with Lung Cancer Screening, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
A nationwide population-based multi-center RCT enrolling ≥60,000 eligible residents to compare screening effectiveness between risk-prediction-model-driven and traditional guideline-based high-risk lung cancer screening strategies. 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 Screening
- What is being tested?
- Prediction Model Arm and Standard Screening Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Nov 2028
- 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
- Residents with local household registration residing continuously in the region for ≥3 years.
- Aged 40-74 years at enrollment.
Who cannot join
- Prior diagnosis of lung cancer (histologically/cytologically confirmed)
- Currently receiving active treatment for any malignancy.
- Presence of severe comorbidities with life expectancy <5 years
- Participation in any lung cancer screening program within 5 years.
- Functional dependency (ADL score ≤2) OR unwillingness to comply with protocol-required follow-up.
- Declined to provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A nationwide population-based multi-center RCT enrolling ≥60,000 eligible residents to compare screening effectiveness between risk-prediction-model-driven and traditional guideline-based high-risk lung cancer screening strategies.
- Conditions
- Lung Cancer Screening
- Being tested
- Prediction Model Arm, Standard Screening Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction Model ArmDiagnostic test
Also called Lung Cancer Risk Prediction Model Arm
Lung cancer risk stratification via prediction model integrating: advanced age, lung cancer family history, personal cancer history, childhood coal exposure, asthma history, and food allergy history. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.
Standard Screening ArmDiagnostic test
Also called Traditional High-Risk Factors Arm
Participants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.
| Study group | Role | What they receive |
|---|---|---|
| Prediction Model Arm | Experimental | Lung Cancer Risk Prediction Model Arm Receives: Diagnostic Test: Prediction Model Arm |
| Standard Screening Arm | Active comparator | Traditional High-Risk Factors Arm Receives: Diagnostic Test: Standard Screening Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of Screening Strategies
Proportion of true lung cancer cases among participants with positive screening results, confirmed by histopathology within 3 months after screening. Calculated as: (True Positives) / (True Positives + False Positives) × 100%. Assessed separately for both screening arms.
Measured: From enrollment through completion of diagnostic confirmation (up to 3 months post-screening)
Secondary outcomes (6)
Sensitivity of Screening Strategies
Proportion of true lung cancer cases correctly identified by screening, confirmed through histopathology within 6 months. Calculated as: True Positives / (True Positives + False Negatives) × 100%. Includes interval cancers detected within 12 months post-screening
Measured: From screening to 12-month follow-up
Specificity of Screening Strategies
Proportion of cancer-free participants correctly identified as screening-negative. Calculated as: True Negatives / (True Negatives + False Positives) × 100%. Cancer-free status confirmed by 12-month follow-up
Measured: From screening to 12-month follow-up
Negative Predictive Value (NPV)
Proportion of screening-negative participants without lung cancer. Calculated as: True Negatives / (True Negatives + False Negatives) × 100%. Absence of cancer confirmed by 12-month follow-up including LDCT and clinical evaluation.
Measured: From screening to 12-month follow-up
Early-Stage Shift Proportion
Percentage of screen-detected lung cancer cases diagnosed at early stage (AJCC 8th ed. Stage I-II) versus late stage (Stage III-IV). Calculated as: (Early-stage cases) / (Total screen-detected cases) × 100%.
Measured: At time of cancer diagnosis (within 3 months post-positive screening)
Lung Cancer-Specific Mortality Rate
Death rate attributable to lung cancer, verified by independent mortality review committee using ICD-10 codes (C34.0-C34.9) and medical records. Expressed as deaths per 1,000 person-years.
Measured: From randomization to 3-year follow-up
Overall Survival in Screen-Detected Lung Cancer
Time from pathological diagnosis of lung cancer to death from any cause. Assessed using Kaplan-Meier method with censoring at last follow-up. Reported as median survival with 95% CI.
Measured: From cancer diagnosis to 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60,000 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078032
- Sponsor's protocol ID
- 20250711
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jul 2025
- 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
- ClinicalTrials.gov ID
- NCT07078032
- Acronym / sponsor ID
- 20250711
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Jul 2025 (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.
A nationwide population-based multi-center RCT enrolling ≥60,000 eligible residents to compare screening effectiveness between risk-prediction-model-driven and traditional guideline-based high-risk lung cancer screening strategies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediction Model Arm | Experimental | Diagnostic Test: Prediction Model ArmLung Cancer Risk Prediction Model Arm |
| Standard Screening Arm | Active comparator | Diagnostic Test: Standard Screening ArmTraditional High-Risk Factors Arm |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residents with local household registration residing continuously in the region for ≥3 years.
- Aged 40-74 years at enrollment.
Key exclusion criteria (6 listed)
- Prior diagnosis of lung cancer (histologically/cytologically confirmed)
- Currently receiving active treatment for any malignancy.
- Presence of severe comorbidities with life expectancy <5 years
- Participation in any lung cancer screening program within 5 years.
- Functional dependency (ADL score ≤2) OR unwillingness to comply with protocol-required follow-up.
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 |
|---|---|---|
| Prediction Model ArmAlso: Lung Cancer Risk Prediction Model ArmLung cancer risk stratification via prediction model integrating: advanced age, lung cancer family history, personal cancer history, childhood coal exposure, asthma history, and food allergy history. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases. | Diagnostic test | Prediction Model Arm |
| Standard Screening ArmAlso: Traditional High-Risk Factors ArmParticipants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases. | Diagnostic test | Standard Screening Arm |
Primary outcome
Positive Predictive Value (PPV) of Screening Strategies
Time frame: From enrollment through completion of diagnostic confirmation (up to 3 months post-screening)
Proportion of true lung cancer cases among participants with positive screening results, confirmed by histopathology within 3 months after screening. Calculated as: (True Positives) / (True Positives + False Positives) × 100%. Assessed separately for both screening arms.
6 secondary outcomes
Sensitivity of Screening Strategies
Time frame: From screening to 12-month follow-up
Specificity of Screening Strategies
Time frame: From screening to 12-month follow-up
Negative Predictive Value (NPV)
Time frame: From screening to 12-month follow-up
Early-Stage Shift Proportion
Time frame: At time of cancer diagnosis (within 3 months post-positive screening)
Lung Cancer-Specific Mortality Rate
Time frame: From randomization to 3-year follow-up
Overall Survival in Screen-Detected Lung Cancer
Time frame: From cancer diagnosis to 3-year follow-up
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 22 Jul 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Prediction Model Arm and Standard Screening Arm in people with Lung Cancer Screening, run by The First Affiliated Hospital of Guangzhou Medical University.
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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 professor, doctor (+86 020-83062808, liangwh1987@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) of Screening Strategies (time frame: From enrollment through completion of diagnostic confirmation (up to 3 months post-screening)). 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 22 Jul 2025.