Lung CancerALIANCT07766538

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

A study testing Low-dose computed tomography (LDCT) lung cancer screening in people with Lung Cancer and Lung Neoplasms, run by Sulaiman Khadadah at 1 site in Kuwait.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Lung Cancer, Lung Neoplasms
What is being tested?: Low-dose computed tomography (LDCT) lung cancer screening
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 1 siteKuwait
Study dates: 1 Sep 2026to 31 Aug 2029
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sulaiman Khadadah, MD contact

+96555966111

khadadas@tcd.ie

Kuwait1 site

Lung Cancer Screening Clinic, Chest Diseases Hospital
Kuwait City
Sulaiman Khadadah, +96555966111, khadadas@tcd.ie

Other trials in Kuwait

About this study

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

Conditions: Lung Cancer, Lung Neoplasms
Being tested: Low-dose computed tomography (LDCT) lung cancer screening
Keywords: lung cancer screening, low-dose computed tomography, Lung-RADS, artificial intelligence, shisha waterpipe smoking, Kuwait, pilot feasibility study
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low-dose computed tomography (LDCT) lung cancer screeningProcedure or surgery
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.

Study groups in NCT07766538
Study group	Role	What they receive
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. Receives: Procedure: Low-dose computed tomography (LDCT) lung cancer screening

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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.
Measured: 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).
Measured: 24 months from start of recruitment
Lung-RADS category distribution
Proportion of baseline scans classified as Lung-RADS 1-2, 3, 4A, and 4B/4X.
Measured: 12 months from start of recruitment
Artificial intelligence software performance
Concordance of AI-based nodule detection and Lung-RADS categorization with radiologist reading (sensitivity, specificity, agreement).
Measured: 24 months from start of recruitment
Radiation exposure
Mean effective dose (mSv) per LDCT examination and cumulative effective dose per participant.
Measured: 24 months from start of recruitment
Incidental findings rate
Proportion of scans with clinically significant incidental findings (Lung-RADS modifier S).
Measured: 12 months from start of recruitment
Adherence to recommended follow-up
Proportion of participants completing recommended follow-up imaging (annual round 2, or short-interval CT at 3 or 6 months).
Measured: 24 months from start of recruitment
Participant-reported experience and distress
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).
Measured: 24 months from start of recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202631 Aug 2029

First posted14 Aug 2026
Study start1 Sep 2026 (estimated)
Primary completion30 Sep 2027 (estimated)
Study completion31 Aug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07766538
Sponsor's protocol ID: 2025/2826
Other IDs: PP25-1AH-0001
Acronym: ALIA
Status last verified: Aug 2026
First submitted: 9 Aug 2026
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data underlying published results will be made available to researchers on reasonable request to the Principal Investigator after publication of the main study results, subject to approval by the study team and Kuwait Ministry of Health data-governance requirements.