Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorSulaiman Khadadah
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Low-dose computed tomography (LDCT) lung cancer screening
Procedure/SurgeryLow-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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: LDCT screeningOther 1 intervention
Trial outcomes
Primary outcomes
1
Consent rate (co-primary outcome P1)
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.
Time frame
12 months from start of recruitment2
Baseline LDCT scan completion rate (co-primary outcome P2)
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.
Time frame
15 months from start of recruitment (12-month recruitment period plus 90-day scan-completion window)Secondary outcomes
1
Barriers to screening participation
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.
Time frame
12 months from start of recruitment2
Lung cancer detection rate and stage distribution
Number and proportion of screen-detected lung cancers, by TNM stage (stage I-II vs III-IV).
Time frame
24 months from start of recruitment3
Lung-RADS category distribution
Proportion of baseline scans classified as Lung-RADS 1-2, 3, 4A, and 4B/4X.
Time frame
12 months from start of recruitment4
Artificial intelligence software performance
Concordance of AI-based nodule detection and Lung-RADS categorization with radiologist reading (sensitivity, specificity, agreement).
Time frame
24 months from start of recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sulaiman Khadadah
Lead sponsor
Chest Diseases Hospital, Ministry of Health, Kuwait
Sponsor institution
Kuwait Foundation for the Advancement of Sciences
Collaborator
Ministry of Health, Kuwait
Collaborator
Source ClinicalTrials.gov
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