Clinical trial · Interventional
China Lung Cancer Screening (CLUS) Study Version 2.0
Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| artificial intelligence (AI) | Device | — | UNRESOLVED |
| autofluorescence imaging (AFI) | Diagnostic Test | — | UNRESOLVED |
| Low Dose Computed Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- LDCT Screening
- description
- LDCT was performed at baseline + 2 biennial repeated LDCT rounds
- interventionNames
- Device: Low Dose Computed Tomography
- Device: artificial intelligence (AI)
- Diagnostic Test: autofluorescence imaging (AFI)
Primary outcomes (3)
- measure
- The mortality rate of lung cancer
- timeFrame
- 5 years
- description
- Assess lung cancer mortality within next 5 years after first round of screening
- measure
- The attendance rate of high-risk individuals
- timeFrame
- 5 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible participants were those aged 45-75 years, and with either of the following risk factors: 1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2. malignant tumors history in immediate family members; 3. personal cancer history; 4. professional exposure to carcinogens; 5. long term exposure to second-hand smoke; 6. long term exposure to cooking oil fumes. Exclusion Criteria: 1. Had a CT scan of chest within last 12 months 2. History of any cancer within 5 years
References
Publications (1)
- DERIVEDZhang Y, Liu W, Zhang H, Sun B, Chen T, Hu M, Zhou H, Cao Y, Han B, Wu L. Extracellular vesicle long RNA markers of early-stage lung adenocarcinoma. Int J Cancer. 2023 Apr 1;152(7):1490-1500. doi: 10.1002/ijc.34386. Epub 2022 Dec 15. PMID 36451312