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NCT Number: NCT07766538

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

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.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lung Cancer Screening Clinic, Chest Diseases Hospital

Kuwait City, Kuwait

Location contact

Sulaiman Khadadah

CONTACT

[email protected]

+96555966111

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Consent rate (co-primary outcome P1)

    Time frame: 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.

  2. Baseline LDCT scan completion rate (co-primary outcome P2)

    Time frame: 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 outcomes

  1. Barriers to screening participation

    Time frame: 12 months from start of recruitment

    Reasons for declining screening among eligible individuals, collected with a structured decline questionnaire, and barrier themes reported by participants.

  2. Lung cancer detection rate and stage distribution

    Time frame: 24 months from start of recruitment

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

  3. Lung-RADS category distribution

    Time frame: 12 months from start of recruitment

    Proportion of baseline scans classified as Lung-RADS 1-2, 3, 4A, and 4B/4X.

  4. Artificial intelligence software performance

    Time frame: 24 months from start of recruitment

    Concordance of AI-based nodule detection and Lung-RADS categorization with radiologist reading (sensitivity, specificity, agreement).

  5. Radiation exposure

    Time frame: 24 months from start of recruitment

    Mean effective dose (mSv) per LDCT examination and cumulative effective dose per participant.

  6. Incidental findings rate

    Time frame: 12 months from start of recruitment

    Proportion of scans with clinically significant incidental findings (Lung-RADS modifier S).

  7. Adherence to recommended follow-up

    Time frame: 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).

  8. Participant-reported experience and distress

    Time frame: 24 months from start of recruitment

    Participant worry and satisfaction measured with study questionnaires at baseline, post-CT, results visit, and exit.

Study contacts

Contact information is provided by the study sponsor or research team.

Sulaiman Khadadah, MD

CONTACT

[email protected]

+96555966111

Sponsors and collaborators

Lead sponsor

Sulaiman Khadadah

Other Gov

Collaborators

  • Kuwait Foundation for the Advancement of Sciences
  • Ministry of Health, Kuwait

Registry information

Official study title

ALIA Kuwait: A Prospective Pilot Feasibility Study of Low-Dose Computed Tomography Screening for Lung Cancer in High-Risk Individuals in Kuwait

Acronym: ALIA

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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