ALIA Kuwait: A Prospective Pilot Feasibility Study of Low-Dose Computed Tomography Screening for Lung Cancer in High-Risk Individuals in Kuwait
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Consent rate (co-primary outcome P1)
研究概览
简要总结
Lung cancer is a leading cause of cancer-related death in Kuwait, where most cases are diagnosed at an advanced stage and there is no national screening program. This prospective pilot feasibility study will offer low-dose computed tomography (LDCT) screening to approximately 500 high-risk individuals aged 50-80 years across Kuwait. The primary objective is to assess the uptake of, and barriers to, LDCT lung cancer screening in Kuwait and to establish a framework for a national screening program. Participants undergo eligibility assessment (smoking history of at least 20 pack-years, totalled across all tobacco products using pre-specified equivalency conversions for shisha/waterpipe, cigar, pipe, and roll-your-own tobacco), baseline assessment, LDCT screening with Lung-RADS-based management, a second screening round at 12 months, and follow-up. LDCT images are read by radiologists and in parallel by artificial intelligence (AI) software to evaluate AI-assisted reading. Findings will inform national lung cancer screening guidelines for Kuwait.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 to 80 years
- •Smoking history of at least 20 pack-years, totalled across all tobacco products using pre-specified equivalency conventions (1 shisha head-year = 1 pack-year; 1 cigar = 4 cigarettes; 1 pipe bowl = 2.5 cigarettes; roll-your-own tobacco 1 g = 1 cigarette). Current and former smokers are eligible regardless of time since quitting.
- •Able to provide informed consent
排除标准
- •Previous diagnosis of lung cancer
- •Currently under surveillance for pulmonary nodules
- •Currently undergoing diagnostic assessment, treatment, or surveillance for major comorbidities
- •Unable to lie flat with arms raised above the head for CT scanning
- •Symptoms suggestive of lung cancer (persistent or worsening cough, haemoptysis, or unexplained weight loss of more than 7 kg in the past year)
研究组 & 干预措施
LDCT screening
All enrolled participants undergo baseline assessment and low-dose CT screening at enrollment and a second round at 12 months (Lung-RADS 1-2), with short-interval CT at 6 or 3 months for Lung-RADS 3 or 4A respectively, and diagnostic work-up/multidisciplinary team referral for Lung-RADS 4B-4X. CT images are read by a radiologist and independently analyzed by AI software.
干预措施: Low-dose computed tomography (LDCT) lung cancer screening (Procedure)
结局指标
主要结局
Consent rate (co-primary outcome P1)
时间窗: 12 months from start of recruitment
Proportion of eligible individuals approached who consent to participate in screening. Co-primary outcome P1. Overall screening uptake (the proportion of eligible approached individuals who receive an adequate baseline scan, computed on the evaluable cohort) is additionally reported as a descriptive measure in the participant flow diagram.
Baseline LDCT scan completion rate (co-primary outcome P2)
时间窗: 15 months from start of recruitment (12-month recruitment period plus 90-day scan-completion window)
Proportion of consented, evaluable participants who complete a technically adequate baseline LDCT scan within 90 days of consent. The evaluable cohort comprises consented participants whose consent date precedes data lock by at least 90 days (a full 90-day opportunity window); participants consented fewer than 90 days before data lock are excluded from the denominator as not yet evaluable. Participants who withdraw after consent are counted as non-completers. Co-primary outcome P2.
次要结局
- Lung cancer detection rate and stage distribution(24 months from start of recruitment)
- Lung-RADS category distribution(12 months from start of recruitment)
- Artificial intelligence software performance(24 months from start of recruitment)
- Radiation exposure(24 months from start of recruitment)
- Incidental findings rate(12 months from start of recruitment)
- Adherence to recommended follow-up(24 months from start of recruitment)
- Barriers to screening participation(12 months from start of recruitment)
- Participant-reported experience and distress(24 months from start of recruitment)
研究者
Sulaiman Khadadah
Principal Investigator
Chest Diseases Hospital, Ministry of Health, Kuwait