Clinical trial NCT03992833: Methods of Computed Tomography Screening and Management of Lung Cancer
Official title: Methods of Computed Tomography Screening and Management of Lung Cancer in Tianjin: A Population-based Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Computed Tomography
Mass Screening
Lung Nodules
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Shanghai Changzheng Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2019-06-20
Enrollment: 4000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of clinically diagnosed lung cancer
timeFrame: at the fourth year from baseline
measure: number of lung cancer death
timeFrame: at the fourth year from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute And Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhaoxiang Ye, Professor
role: PRINCIPAL_INVESTIGATOR
References: