NCT07478757

Brief Summary

The investigators propose a randomized controlled trial to evaluate the clinical effectiveness of low-dose computed tomography (LDCT) for lung cancer screening in high-risk Chinese ever-smokers aged 50-79 years in Hong Kong and to assess the cost-effectiveness of implementing LDCT for lung cancer screening in the local setting.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
134mo left

Started Jul 2026

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2032

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2037

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

March 12, 2026

Last Update Submit

March 12, 2026

Conditions

Lung CancerLung Cancer Screening

Keywords

Lung CancerLow-dose computed tomography (LDCT)ScreeningHigh-risk smokers

Outcome Measures

Primary Outcomes (1)

  • Lung cancer mortality

    Defined as the lung cancer-related death. The survival status of diagnosed lung cancer patients in both arms will be reviewed yearly after the first five years up to 10 years through Hospital Authority of Hong Kong (HA)'s Data Sharing Portal services or the Deaths Registry, supplemented by access to Clinical Management System (CMS) if needed. The lung cancer mortality rate will be calculated by dividing (a) the number of lung cancer-related deaths by (b) the number of person-years.

    10 years

Secondary Outcomes (6)

  • Stage distribution of lung cancer cases

    10 years

  • Lung cancer incidence

    10 years

  • Prevalence of false-positive of screening cases

    10 years

  • Percentage of overdiagnosis of lung cancer cases

    10 years

  • Prevalence of radiation-induced cancers

    10 years

  • +1 more secondary outcomes

Study Arms (2)

SCREEN Arm

ACTIVE COMPARATOR

SCREEN Arm: 3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline

Diagnostic Test: Low-dose computed tomography (LDCT)

CONTROL arm

NO INTERVENTION

CONTROL arm: No LDCT screening

Interventions

Low-dose computed tomography (LDCT)DIAGNOSTIC_TEST

3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline

SCREEN Arm

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged between 50 and 79 years
  • Current smokers or ex-smokers quitted for less than 10 years, with a history of cigarette smoking equivalent to at least 20 pack-years

You may not qualify if:

  • Non-Chinese population
  • Individuals who are not mentally competent to provide informed consent (e.g., those with a history of dementia)
  • Individuals with a known prior diagnosis of lung cancer or detection of lung nodules
  • Individuals with a history of other cancers within the last five years or currently under treatment
  • Individuals who have undergone a CT scan of the thorax in the previous 12 months
  • Individuals who are either unwilling to undergo a chest LDCT scan, or having a condition that prevents them from having a LDCT scan (for example, pregnancy or inability to lie flat on the CT table)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Dennis KM Ip, MD

    School of Public Health, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa HC So

CONTACT

(+852) 39176714haso9150@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2032

Study Completion (Estimated)

June 30, 2037

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)