Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai, China

Not Applicable

• Conditions: Lung Neoplasms; Chronic Obstructive Pulmonary Disease; Mass Screening; Cardiovascular Disease

• Registration Number: NCT03988322
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-14
• Last Update Submitted: 2019-06-14
• Study First Posted: 2019-06-17
• Last Update Posted: 2019-06-17
• Primary Completion: 2021-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of incident lung cancer	at the fourth year from baseline	The number of clinically diagnosed lung cancer will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
number of COPD	at the fourth year from baseline	The number of clinically diagnosed COPD, the number of hospitalization due to COPD and the number of acute exacerbation will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.
number of cardiovascular event	at the fourth year from baseline	The number of cardiovascular event(eg, major adverse cardiovascular event, myocardial infarction, stroke)will be collected through the Hospital Information System (HIS) of Shanghai Changzheng Hospital and from the general practitioners by using a pre-defined questionnaire.

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China