Lung Cancer Screening by Artificial Intelligence Device - Trial NCT06295497
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Study Focus
Sponsor & Location
Chinese University of Hong Kong
Timeline & Enrollment
N/A
Apr 01, 2024
Dec 31, 2027
Primary Outcome
The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population
Summary
Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence.
 Emerging evidence suggests that first-degree family history is a strong risk factor for lung
 cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful
 implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to
 overcome this resource. In this study, we aim to study the clinical utility and demonstrate
 the feasibility of using an AI assisted programme for lung cancer screening in Asian
 non-smokers with a positive family history. This is a single-arm non-randomized lung cancer
 screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history
 of lung cancer, will be enrolled. Participants will undergo low does computed tomography
 (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI
 softwares for presence of lung nodules. Participants with lung nodules will be further
 investigated and followed up according to the risk of malignancy. The primary endpoint is the
 prevalence of early-staged lung cancer detected by first-round LDCT thorax in this
 population.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06295497
Device Trial