NCT06295497Recruiting
Lung Cancer Screening in HIgh Risk nonsmokErs by Artificial inteLligence Device
A Prospective Study on Artificial Intelligence Guided Lung Cancer Screening for High-risk Never Smokers in Hong Kong
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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. 3000 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3000 (estimated)
- First submitted
- 18 Feb 2024
- Start date
- 18 Jul 2024
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Lung cancer
- NCT number
- NCT06295497
What you commit to
- Study type: Interventional
- Planned participants: 3000
- From 18 Jul 2024 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of malignancy
- Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss
- Medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder
- History of tuberculosis or interstitial lung disease
- CT thorax or chest performed within 2 years (including LDCT, PET-CT, MRI thorax or suspicious of lung cancer)
Other
- Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study:
- Smoking history (defined as more than 100 cigarettes in lifetime)
- Pregnant ladies or ladies planning for conception
- Pneumonia requiring antibiotic treatment within the last 12 weeks
- Unable or unwilling to provide written informed consent
Who the study is looking for
- Patients are eligible to be included in the study only if all of the following criteria apply:
- Age 50-75 years old
- Non-smoker (defined as less than 100 cigarettes in lifetime)
- Having a first-degree family history of lung cancer
- Physically fit for curative treatment if early-staged lung cancer is found
- Able to provide written informed consent
- Consent to follow up visits and follow up CT scan if indicated
- Consent to blood taking for translational research
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.