Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait

N/ANot Yet RecruitingNCT07766538

Sulaiman Khadadah500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

500

Conditions

Lung Cancer Lung Neoplasms

Low-dose computed tomography (LDCT) lung cancer screeningPROCEDURE

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Lung Cancer Screening Clinic, Chest Diseases Hospital

Kuwait City, Kuwait

Outcomes

Primary Outcomes

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 recruitment

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

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 recruitment

Lung cancer detection rate and stage distribution

Number and proportion of screen-detected lung cancers, by TNM stage (stage I-II vs III-IV).