Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai: a Population-based Comparative Study
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.
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.
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