Computed Tomography, Lung Neoplasms, Lung Nodules, Mass Screening
Conditions
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.
Interventions
OTHERlung 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).
Sponsors
University Medical Center Groningen
Shanghai Changzheng Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhaoxiang Ye, Professor
Outcome results
None listed