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.
Trial 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 offers low-dose computed tomography (LDCT) screening to high-risk individuals aged 50-80 years (about 590… Read more about this study
- 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
- 590 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Sep 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 smoked tobacco products (cigarettes, shisha/waterpipe, cigars, pipe and roll-your-own tobacco) 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). Electronic cigarettes, heated tobacco and smokeless products do not count. Current and former smokers are eligible regardless of time since quitting.
- Able to provide informed consent
Who cannot join
- Previous diagnosis of lung cancer or any other cancer
- Currently under surveillance for pulmonary nodules
- A major comorbidity under active management (for example end-stage heart, lung or liver disease); people whose condition is under routine follow-up, such as COPD on inhaled treatment, bronchiectasis or interstitial lung disease, remain eligible
- 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 15 lb (about 7 kg) in the past 3-12 months); symptomatic people are referred the same day on the normal diagnostic pathway
- Chest CT for any reason in the past 12 months
- Non-Kuwaiti residents who have lived in Kuwait for less than 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kuwait1 site, 1 recruiting
- Recruiting
Lung Cancer Screening Clinic, Chest Diseases Hospital
Kuwait City
Sulaiman Khadadah, +96555966111, khadadas@tcd.ie
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 offers low-dose computed tomography (LDCT) screening to high-risk individuals aged 50-80 years (about 590 participants, so that about 500 complete a baseline scan), recruited by physicians at Ministry of Health polyclinics and hospital chest clinics and screened at the Chest Diseases Hospital. 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 smoked tobacco products using pre-specified equivalency conversions for shisha/waterpipe, cigar, pipe, and roll-your-own tobacco), baseline assessment, and are offered three LDCT screening rounds (a baseline scan and two annual rounds) with Lung-RADS-based management and follow-up. Scans are read by radiologists without artificial intelligence (AI); at the end of the study, AI software is run once on the archived scans in a separate reader study. Findings will inform national lung cancer screening guidelines for Kuwait.
Read the detailed description
Participants are recruited by physicians at Ministry of Health sites: at present eight designated polyclinics, where smoking-cessation sessions are the main recruitment channel, and the respiratory or chest clinics of five MOH hospitals; further polyclinics may be added. All screening is performed at the Chest Diseases Hospital. Each participant is offered three screening rounds (a baseline scan and two annual rounds); short-interval scans are not counted as rounds. The primary cohort closes at 500 signed consents or at 12 months, whichever comes first; participants consented after it closes form an extension cohort, which is excluded from the co-primary outcomes but included in scan-based analyses.
- 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 by a radiologist using Lung-RADS v2022, without AI. 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 (Lung-RADS modifier S) are managed at the results consultation by referral, advice or no action, according to the study's threshold-based referral routing table. At the end of the study, AI software (AVIEW LCS+, Coreline Soft) is run once on the archived scans, with one fixed software version, in a separate reader study; AI output is not used in clinical care.
| Study group | Role | What they receive |
|---|---|---|
| LDCT screening | Other | All enrolled participants undergo baseline assessment and low-dose CT screening at enrollment and are offered two further annual screening rounds (three rounds in total). Lung-RADS 1-2: next annual round; Lung-RADS 3 or 4A: short-interval CT at 6 or 3 months respectively; Lung-RADS 4B-4X: same-day referral to the rapid access and lung nodule clinic for diagnostic work-up and multidisciplinary team review. CT images are read by a radiologist without AI. 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 eligible individuals approached at least 120 days before data lock) 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 approached, collected on the eligibility form with a structured decline checklist and the participant's stated main reason recorded verbatim in their own words and language; reasons are classified into barrier domains by two independent coders blinded to participant characteristics. Reported as frequencies and proportions of barrier domains; 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: From the baseline LDCT to the round 3 LDCT, including diagnostic work-up of positive scans (approximately 24 months after each participant's baseline scan)
Lung-RADS category distribution
Proportion of baseline scans classified as Lung-RADS 1-2, 3, 4A, and 4B/4X.
Measured: At the baseline LDCT (within 90 days of consent)
Artificial intelligence software performance (end-of-study reader study)
Per-nodule sensitivity and number of false positives per scan for the unaided radiologist, AI alone and the AI-assisted radiologist, against a reference standard of all nodules found by any reader or by the AI and confirmed by an independent expert thoracic radiologist.
Measured: Each participant's LDCT scans from baseline to round 3 (approximately 24 months), analysed once at the end of the study
Radiation exposure
Mean effective dose (mSv) per LDCT examination and cumulative effective dose per participant.
Measured: Each LDCT from baseline to the round 3 LDCT (approximately 24 months after each participant's baseline scan)
Incidental findings rate
Proportion of scans with clinically significant incidental findings referred for further assessment, counted from the referral decisions made at the results consultation (readers also assign Lung-RADS modifier S on the report).
Measured: At the results consultation after each screening LDCT, from baseline to round 3 (approximately 24 months)
Adherence to recommended follow-up
Proportion of participants completing recommended follow-up imaging (annual screening rounds 2 and 3, or short-interval CT at 3 or 6 months).
Measured: From the baseline LDCT to the round 3 LDCT (approximately 24 months after baseline; later when short-interval CT moves a round)
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: Baseline, after the baseline LDCT, at the round 1 results consultation, and at study exit after round 3 (approximately 24 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2026
- Primary completion30 Nov 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
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sulaiman Khadadah
- Sponsor type
- Other government
- Collaborators
- Kuwait Foundation for the Advancement of Sciences, Ministry of Health, Kuwait
- Responsible party
- Sponsor-investigator, Sulaiman Khadadah, Chest Diseases Hospital, Ministry of Health, Kuwait
- Investigators
- Sulaiman Khadadah, MD, Principal investigator, Chest Diseases Hospital, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766538
- Sponsor's protocol ID
- 2025/2826
- Other IDs
- PP25-1AH-0001
- Acronym
- ALIA
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2026
- Last updated
- 3 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALIA Kuwait: A Prospective Pilot Feasibility Study of Low-Dose Computed Tomography Screening for Lung Cancer in High-Risk Individuals in Kuwait
- ClinicalTrials.gov ID
- NCT07766538
- Acronym / sponsor ID
- ALIA / 2025/2826
- Conditions
- Lung Cancer, Lung Neoplasms
- Keywords
- lung cancer screening, low-dose computed tomography, Lung-RADS, artificial intelligence, shisha waterpipe smoking, Kuwait, pilot feasibility study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Sulaiman KhadadahOther government
- Collaborators
- Kuwait Foundation for the Advancement of Sciences, Ministry of Health, Kuwait
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 offers low-dose computed tomography (LDCT) screening to high-risk individuals aged 50-80 years (about 590 participants, so that about 500 complete a baseline scan), recruited by physicians at Ministry of Health polyclinics and hospital chest clinics and screened at the Chest Diseases Hospital. 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 smoked tobacco products using pre-specified equivalency conversions for shisha/waterpipe, cigar, pipe, and roll-your-own tobacco), baseline assessment, and are offered three LDCT screening rounds (a baseline scan and two annual rounds) with Lung-RADS-based management and follow-up. Scans are read by radiologists without artificial intelligence (AI); at the end of the study, AI software is run once on the archived scans in a separate reader study. Findings will inform national lung cancer screening guidelines for Kuwait.
Detailed description
Participants are recruited by physicians at Ministry of Health sites: at present eight designated polyclinics, where smoking-cessation sessions are the main recruitment channel, and the respiratory or chest clinics of five MOH hospitals; further polyclinics may be added. All screening is performed at the Chest Diseases Hospital. Each participant is offered three screening rounds (a baseline scan and two annual rounds); short-interval scans are not counted as rounds. The primary cohort closes at 500 signed consents or at 12 months, whichever comes first; participants consented after it closes form an extension cohort, which is excluded from the co-primary outcomes but included in scan-based analyses.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDCT screening | Other | Procedure: Low-dose computed tomography (LDCT) lung cancer screeningAll enrolled participants undergo baseline assessment and low-dose CT screening at enrollment and are offered two further annual screening rounds (three rounds in total). Lung-RADS 1-2: next annual round; Lung-RADS 3 or 4A: short-interval CT at 6 or 3 months respectively; Lung-RADS 4B-4X: same-day referral to the rapid access and lung nodule clinic for diagnostic work-up and multidisciplinary team review. CT images are read by a radiologist without AI. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 to 80 years
- Smoking history of at least 20 pack-years, totalled across all smoked tobacco products (cigarettes, shisha/waterpipe, cigars, pipe and roll-your-own tobacco) 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). Electronic cigarettes, heated tobacco and smokeless products do not count. Current and former smokers are eligible regardless of time since quitting.
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Previous diagnosis of lung cancer or any other cancer
- Currently under surveillance for pulmonary nodules
- A major comorbidity under active management (for example end-stage heart, lung or liver disease); people whose condition is under routine follow-up, such as COPD on inhaled treatment, bronchiectasis or interstitial lung disease, remain eligible
- 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 15 lb (about 7 kg) in the past 3-12 months); symptomatic people are referred the same day on the normal diagnostic pathway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose computed tomography (LDCT) lung cancer screeningLow-dose chest CT without contrast, reported by a radiologist using Lung-RADS v2022, without AI. 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 (Lung-RADS modifier S) are managed at the results consultation by referral, advice or no action, according to the study's threshold-based referral routing table. At the end of the study, AI software (AVIEW LCS+, Coreline Soft) is run once on the archived scans, with one fixed software version, in a separate reader study; AI output is not used in clinical care. | Procedure or surgery | LDCT screening |
Primary outcome
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 eligible individuals approached at least 120 days before data lock) is additionally reported as a descriptive measure in the participant flow diagram.
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.
8 secondary outcomes
Barriers to screening participation
Time frame: 12 months from start of recruitment
Lung cancer detection rate and stage distribution
Time frame: From the baseline LDCT to the round 3 LDCT, including diagnostic work-up of positive scans (approximately 24 months after each participant's baseline scan)
Lung-RADS category distribution
Time frame: At the baseline LDCT (within 90 days of consent)
Artificial intelligence software performance (end-of-study reader study)
Time frame: Each participant's LDCT scans from baseline to round 3 (approximately 24 months), analysed once at the end of the study
Radiation exposure
Time frame: Each LDCT from baseline to the round 3 LDCT (approximately 24 months after each participant's baseline scan)
Incidental findings rate
Time frame: At the results consultation after each screening LDCT, from baseline to round 3 (approximately 24 months)
Adherence to recommended follow-up
Time frame: From the baseline LDCT to the round 3 LDCT (approximately 24 months after baseline; later when short-interval CT moves a round)
Participant-reported experience and distress
Time frame: Baseline, after the baseline LDCT, at the round 1 results consultation, and at study exit after round 3 (approximately 24 months after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Paper 1A outcomes and hypotheses, v2.8. OSF Registries, registered 30 October 2026 (doi:10.17605/OSF.IO/KPX7Z)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sulaiman Khadadah, MD principal investigator
Chest Diseases Hospital, Ministry of Health, Kuwait
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sulaiman Khadadah, MD (+96555966111, khadadas@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (co-primary outcome P1) (time frame: 12 months from start of recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.