Clinical trial NCT06295497: Lung Cancer Screening by Artificial Intelligence Device
Official title: Lung Cancer Screening in High Risk NonsmokErs by Artificial InteLligence Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

Patients are eligible to be included in the study only if all of the following criteria apply:

1. Age 50-75 years old
2. Non-smoker (defined as less than 100 cigarettes in lifetime)
3. Having a first-degree family history of lung cancer
4. Physically fit for curative treatment if early-staged lung cancer is found
5. Able to provide written informed consent
6. Consent to follow up visits and follow up CT scan if indicated
7. Consent to blood taking for translational research

Exclusion Criteria:

Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study:

1. History of malignancy
2. Smoking history (defined as more than 100 cigarettes in lifetime)
3. Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss
4. 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
5. Pregnant ladies or ladies planning for conception
6. History of tuberculosis or interstitial lung disease
7. Pneumonia requiring antibiotic treatment within the last 12 weeks
8. CT thorax or chest performed within 2 years (including LDCT or CT coronary angiogram)
9. Unable or unwilling to provide written informed consent

Primary outcomes:
measure: The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population
timeFrame: 2 years
Secondary outcomes:
measure: Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment
timeFrame: 2 years
measure: Rate of invasive workup and incidence of associated complications.
timeFrame: 2 years
measure: Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT
timeFrame: 2 years
measure: Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value
timeFrame: 2 years
measure: To determine the quality adjusted life years (QALYs) gained through screening
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
References: