Methods of Computed Tomography Screening and Management of Lung Cancer

Not Applicable

• Conditions: Lung Neoplasms; Computed Tomography; Lung Nodules; Mass Screening

• Registration Number: NCT03992833
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

European lung cancer screening studies using computed tomography (CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time (VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.

Detailed Description

In this population-based study, participants will undergo a low-dose chest CT scan for two rounds. At baseline, the first CT scan will be performed in all participants and their data will be collected. One-year after the baseline, a second CT scan will be performed and data will be collected again. CT images of each participant will be read twice independently by two groups of readers after the baseline and 1-year follow-up scans. In the first reading, the detected lung nodules are evaluated for diameter and managed according to a routine diameter-based protocol. The clinical management of participants are based on the first reading. In the second reading, each scan will be interpreted again by radiologists, blinded to the first reading. Semi-automated volumetry software will be used. The lung nodules will be evaluated for volume and management will be simulated according to a European volume-based protocol. Participants will be followed up and any diagnosis of lung cancer and related information will be collected at the fourth year through the hospital information system and by contacting the participants or their relatives.

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Study First Posted: 2019-06-20
• Last Update Posted: 2019-06-20
• Primary Completion: 2020-05
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Aged 40-74 years;
• Resident in the Hexi district of Tianjin city for at least 3 years;
• Having no self-reported history of any malignant tumor.

Exclusion Criteria

• Pregnant woman will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of clinically diagnosed lung cancer	at the fourth year from baseline	The number of clinically diagnosed lung cancer will be collected through the hospital information system and by contacting the participants or their relatives using a questionnaire.
number of lung cancer death	at the fourth year from baseline	The number of lung cancer death will be collected through the hospital information system and by contacting the relatives of the participants using a questionnaire.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute And Hospital; 🇨🇳 Tianjin, Tianjin, China