Clinical trial NCT03988322: Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai, China
Official title: Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: a Population-based Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Mass Screening
Chronic Obstructive Pulmonary Disease
Cardiovascular Disease
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Studies in European population showed the benefit of volumetric assessment of CT screening-detected lung nodules compared to diameter-based assessment. Screening for COPD and CVD, in addition to lung cancer, may significantly increase the benefits of low-dose CT lung cancer screening. The objective is to assess the screening performance of volume-based management of CT-detected lung nodule in comparison to diameter-based management, and to improve the effectiveness of CT screening for COPD and CVD, in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. Thus, a population-based comparative study will be performed in Shanghai, China.

Detailed description: The study will recruit 10,000 asymptomatic participants between 40 and 74 years old from Shanghai urban population. The 5000 participants in the intervention group will undergo a low-dose CT scan at baseline and one year later, and will be managed according to European volume-based protocol. The 5000 participants in the control group will undergo a low-dose CT scan according to the routine CT protocol and will be managed according to the clinical practice. Epidemiological data will be collected through questionnaires. In the fourth year from baseline, the diagnosis of the three diseases will be collected. The screening performance will be compared between volume-based and standard protocol for managing early-detected lung nodules. The effectiveness of quantitative measurement of CT imaging biomarkers for early detection of lung cancer, COPD and CVD will be evaluated.

The detected lung nodules in the intervention group will be classified into three groups depending on nodule volume: \< 100 mm3 (negative result), 100-300 mm3 (indeterminate result) and \> 300 mm3 (positive result). In case of a negative result, a CT scan after one year is recommended. In case of an indeterminate result, a 3-month follow up CT is recommended at which VDT will be assessed. For short VDT (\< 400 days), the screening result is positive. Long VDT (\> 400 days) is considered a negative screening result. In case of a positive result, referral to a multidisciplinary team is recommended for further investigation. The detected nodules in the control group will be managed according to the recommended cut-off values of diameter from NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening.

Eligibility criteria: Inclusion Criteria:

1. asymptomatic (without complaints of chest discomfort) residents registered in Shanghai city.
2. age between 40-74 years old
3. no history of lung cancer (self-reported).

Exclusion Criteria:

* Pregnant women will be excluded.

Primary outcomes:
measure: number of incident lung cancer
timeFrame: at the fourth year from baseline
measure: number of COPD
timeFrame: at the fourth year from baseline
measure: number of cardiovascular event
timeFrame: at the fourth year from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Shiyuan Liu, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Du Y, Li Q, Sidorenkov G, Vonder M, Cai J, de Bock GH, Guan Y, Xia Y, Zhou X, Zhang D, Rook M, Vliegenthart R, Heuvelmans MA, Dorrius MD, van Ooijen PMA, Groen HJM, van der Harst P, Xiao Y, Ye Z, Xie X, Wang W, Oudkerk M, Fan L, Liu S. Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: Rationale and Design of a Population-based Comparative Study. Acad Radiol. 2021 Jan;28(1):36-45. doi: 10.1016/j.acra.2020.01.020. Epub 2020 Mar 6.