Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295497
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-02-18
Brief Title:
Lung Cancer Screening by Artificial Intelligence Device
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Lung Cancer Screening in High Risk nonsmokErs by Artificial inteLligence Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None