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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03988322
• Other study ID #: 2016YFE0103000
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 2022

Study information

• Verified date: June 2019
• Source: Shanghai Changzheng Hospital
• Contact: Shiyuan Liu, Prof
• Phone: 021-81886609
• Email: cjr.liushiyuan[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Neoplasms
• Mass Screening
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Low-dose CT screening with quantitative assessment and management of imaging biomarkers
Participants will be screened with a low-dose CT (a Philips 256-slice CT system). The CT images will be obtain according to the pre-defined CT scan protocol. This CT protocol is developed for quantitative assessment of lung nodules, COPD and coronary artery calcium. Detected lung nodules will be managed according to the European volume-based protocol, based on the volume and volume doubling time of lung nodule. COPD will be management according to the result of lung function test. The imaging biomarkers (eg., emphysema index, airway wall thickness, and coronary artery calcium ) will be quantitatively registered. In addition, a number of participants' characteristics will be collected: physical examination (weight, height, blood pressure), laboratory measurements (eg., fasting plasma glucose, total cholesterol, HDL-cholesterol). The social-demographic characteristics, risk factors of the 3 diseases, and health status of the participants will be collected through questionnaires.
• Low-dose CT screening with visual assessment and management of imaging biomarkers
Participants will be screened with a low-dose CT (a Philips 64 MDCT system). The CT images will be obtain according to the routine CT scan protocol for lung cancer screening in the hospital. Detected lung nodules will be managed according to the diameter of the nodule based on the NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening. Detected emphysema and/or bronchial wall thickness, coronary artery calcium will be qualitatively recorded (yes/no).

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of incident lung cancer	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.	at the fourth year from baseline
Primary	number of COPD	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.	at the fourth year from baseline
Primary	number of cardiovascular event	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.	at the fourth year from baseline