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China Lung Cancer Screening (CLUS) Study Version 3.0

NCT05494021 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2022-08-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Whole-process management software

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.

DEVICE

LDCT detection

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

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494021 on ClinicalTrials.gov