NCT03975504

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

August 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

4.9 years

First QC Date

June 4, 2019

Last Update Submit

May 27, 2022

Conditions

Lung Neoplasms

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 AI in enhancing the attendance rate of high-risk individuals

    5 year

  • Diagnostic accuracy rate of lung cancer

    Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer

    5 year

Secondary Outcomes (3)

  • The mortality of all-cause

    5 years

  • The detection rate of lung nodules

    5 year

  • The incidence rate lung cancer

    5 years

Study Arms (1)

LDCT Screening

OTHER

LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Device: Low Dose Computed TomographyDevice: artificial intelligence (AI)Diagnostic Test: autofluorescence imaging (AFI)

Interventions

Low Dose Computed TomographyDEVICE

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

LDCT Screening
artificial intelligence (AI)DEVICE

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

LDCT Screening
autofluorescence imaging (AFI)DIAGNOSTIC_TEST

AFI applied in screening of centrally located SCC.

LDCT Screening

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

Related Publications (1)

  • Zhang Y, Liu W, Zhang H, Sun B, Chen T, Hu M, Zhou H, Cao Y, Han B, Wu L. Extracellular vesicle long RNA markers of early-stage lung adenocarcinoma. Int J Cancer. 2023 Apr 1;152(7):1490-1500. doi: 10.1002/ijc.34386. Epub 2022 Dec 15.

    PMID: 36451312DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray ComputedOptical Imaging

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-RayTomographyInvestigative Techniques

Central Study Contacts

Baohui Han, MD Dr.

CONTACT

861893085821618930858216@163.com

Yanwei Zhang, MD Dr.

CONTACT

8618930599895zhangyw198691@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 5, 2019

Study Start

August 1, 2018

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)