NCT03992833

Methods of Computed Tomography Screening and Management of Lung Cancer

Methods of Computed Tomography Screening and Management of Lung Cancer in Tianjin: A Population-based Cohort Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Neoplasms
• Computed Tomography
• Mass Screening
• Lung Nodules

Interventions

Type	Name	Description
OTHER	lung cancer screening	In the first reading, according to the NCCN lung cancer screening guideline, participants with a solid nodule≤ 5 mm in diameter will be referred to undergo follow-up CT 1 year after the baseline. Participants with a solid nodule 6-14 mm will be referred to undergo follow-up thorax CT 3-6 months after the baseline. Participants with a solid nodule ≥ 15 mm will be referred to a multidisciplinary team for clinical investigation. The simulated management will be based on the volume of lung nodule and volume doubling time from the second reading, lung nodules will be reclassified according to the reference values from the European volume-based lung nodule management protocol. According to the European volume-based protocol, the solid and part-solid lung nodules will be reclassified into three groups: nodules with a volume \< 100 mm3 (negative), nodules with a volume of 100-300 mm3 (indeterminate), and nodules with a volume \> 300 mm3 (positive).

Timeline

• Start date: 2017-05-01
• Primary completion: 2020-05-01
• Completion: 2022-09-01
• First posted: 2019-06-20
• Last updated: 2019-06-20

Locations

1 site across 1 country: China