China Lung Cancer Screening (CLUS) Study Version 2.0

NCT03975504 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2022-06-01

No results posted yet for this study

Summary

Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 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

  • Lung Neoplasms

Interventions

DEVICE

Low Dose Computed Tomography

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

DEVICE

artificial intelligence (AI)

AI was performed in high-risk individuals recruitment and lung nodules management

DIAGNOSTIC_TEST

autofluorescence imaging (AFI)

AFI applied in screening of centrally located SCC.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2023-06-30
Completion
2023-07-31

Countries

  • China

Study Locations

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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 NCT03975504 on ClinicalTrials.gov