NCT05494021

Brief Summary

CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
8mo left

Started Jan 2022

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
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

Study Progress88%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

5 years

First QC Date

August 7, 2022

Last Update Submit

August 7, 2022

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • The mortality rate of lung cancer

    Assess lung cancer mortality within next 5 years after first round of screening

    5 years

  • The attendance rate of high-risk individuals

    Evaluate the ability of whole-process management strategy in enhancing the attendance rate of high-risk individuals

    5 years

  • The adherence rate of high-risk individuals

    Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals

    5 years

Secondary Outcomes (3)

  • The mortality of all-cause

    5 years

  • The detection rate of lung nodules

    5 years

  • The incidence rate lung cancer

    5 years

Study Arms (2)

Whole-process management strategy

EXPERIMENTAL

High-risk individuls are provided with whole-process management strategy, including lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer. LDCT was performed at baseline + 2 biennial repeated LDCT rounds.

Other: Whole-process management softwareDevice: LDCT detection

Rountine screening strategy

ACTIVE COMPARATOR

LDCT was performed at baseline + 2 biennial repeated LDCT rounds.

Device: LDCT detection

Interventions

Whole-process management softwareOTHER

Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.

Whole-process management strategy
LDCT detectionDEVICE

LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Rountine screening strategyWhole-process management strategy

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants were those aged 45-75 years, and with either of the following risk factors:
  • history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  • malignant tumors history in immediate family members;
  • personal cancer history;
  • professional exposure to carcinogens;
  • long term exposure to second-hand smoke;
  • long term exposure to cooking oil fumes.

You may not qualify if:

  • Had a CT scan of chest within last 12 months
  • History of any cancer within 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 9, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)