Lung Cancer, Lung Neoplasms
Conditions
Keywords
lung cancer screening, low-dose computed tomography, Lung-RADS, artificial intelligence, shisha waterpipe smoking, Kuwait, pilot feasibility study
Brief summary
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.
Interventions
PROCEDURELow-dose computed tomography (LDCT) lung cancer screening
Low-dose chest CT without contrast, reported using Lung-RADS. Management and follow-up intervals follow the Lung-RADS category (annual repeat for 1-2; short-interval CT at 6 months for 3 and 3 months for 4A; diagnostic work-up and multidisciplinary team referral for 4B/4X; incidental findings referred per modifier S). All scans are additionally analyzed by artificial intelligence software in parallel with radiologist reading.
Sponsors
Sulaiman Khadadah
Kuwait Foundation for the Advancement of Sciences
Ministry of Health, Kuwait
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent rate (co-primary outcome P1) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung cancer detection rate and stage distribution | 24 months from start of recruitment | Number and proportion of screen-detected lung cancers, by TNM stage (stage I-II vs III-IV). |
| Lung-RADS category distribution | 12 months from start of recruitment | Proportion of baseline scans classified as Lung-RADS 1-2, 3, 4A, and 4B/4X. |
| Artificial intelligence software performance | 24 months from start of recruitment | Concordance of AI-based nodule detection and Lung-RADS categorization with radiologist reading (sensitivity, specificity, agreement). |
| Radiation exposure | 24 months from start of recruitment | Mean effective dose (mSv) per LDCT examination and cumulative effective dose per participant. |
| Incidental findings rate | 12 months from start of recruitment | Proportion of scans with clinically significant incidental findings (Lung-RADS modifier S). |
| Adherence to recommended follow-up | 24 months from start of recruitment | Proportion of participants completing recommended follow-up imaging (annual round 2, or short-interval CT at 3 or 6 months). |
| Participant-reported experience and distress | 24 months from start of recruitment | Participant-reported worry, satisfaction, and psychological distress measured with study questionnaires at baseline, post-CT, results visit, and exit. Lung cancer and radiation worry are single-item scales (range 1-5; higher scores indicate greater worry, a worse outcome). Satisfaction and experience items are 5-point scales (range 1-5; higher scores indicate greater satisfaction, a better outcome). Psychological distress is measured with the Patient Health Questionnaire-4 (PHQ-4; total score range 0-12; higher scores indicate greater anxiety and depression symptoms, a worse outcome). |
| Barriers to screening participation | 12 months from start of recruitment | Reasons for declining screening among eligible individuals, collected with a structured decline questionnaire (categorical response options plus free text), and barrier themes coded from responses. Reported as frequencies and proportions of barrier categories; no scored scale is used for this outcome. |
Countries
Kuwait
Contacts
CONTACTSulaiman Khadadah, MD
PRINCIPAL_INVESTIGATORSulaiman Khadadah, MD
Chest Diseases Hospital, Ministry of Health, Kuwait
Outcome results
None listed