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

NCT07766538 | Not Yet Recruiting

• 2 other identifiers: 2025/2826PP25-1AH-0001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Neoplasms

Keywords

lung cancer screening; low-dose computed tomography; Lung-RADS; artificial intelligence; shisha waterpipe smoking; Kuwait; pilot feasibility study

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  15 months from start of recruitment (12-month recruitment period plus 90-day scan-completion window)

Secondary Outcomes (8)

• Barriers to screening participation

  12 months from start of recruitment

• 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

Study Arms (1)

LDCT screening

OTHER

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.

Procedure: Low-dose computed tomography (LDCT) lung cancer screening

Interventions

Low-dose computed tomography (LDCT) lung cancer screening PROCEDURE

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.

LDCT screening

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sulaiman Khadadah: lead
• Kuwait Foundation for the Advancement of Sciences: collaborator
• Ministry of Health, Kuwait: collaborator

Study Sites (1)

Lung Cancer Screening Clinic, Chest Diseases Hospital

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sulaiman Khadadah, MD

  Chest Diseases Hospital, Ministry of Health, Kuwait

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sulaiman Khadadah, MD

CONTACT

+96555966111; khadadas@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

KU (1)