An interventional study of Low-dose computed tomography (LDCT) lung cancer screening in Lung Cancer and Lung Neoplasms, sponsored by Sulaiman Khadadah. Recruiting at 1 site in Kuwait. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Sulaiman Khadadah · Not applicable, Interventional, and Screening
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.
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 590 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →This is the only study on the registry with Sulaiman Khadadah as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 28, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Low-dose computed tomography (LDCT) lung cancer screening
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.
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.
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)
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.
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).
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
Proportion of baseline scans classified as Lung-RADS 1-2, 3, 4A, and 4B/4X.
Time frame: 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.
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
Mean effective dose (mSv) per LDCT examination and cumulative effective dose per participant.
Time frame: 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).
Time frame: 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).
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
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).
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)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the main results and for at least 5 years thereafter.
Access criteria: Written request to the Principal Investigator with a methodologically sound proposal; data sharing agreement required; requests reviewed by the study team.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2027, 14 months after the start.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 14 months is below that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2027 → Nov 2027, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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