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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Lung Neoplasms; Chronic Obstructive Pulmonary Disease; Mass Screening
• Intervention / Treatment: Other: Low-dose CT screening with quantitative assessment and management of imaging biomarkers; Other: Low-dose CT screening with visual assessment and management of imaging biomarkers

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 Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Changzheng Hospital
    • Contact: Shiyuan Liu, Prof; Phone Number: 021-81886609; Email: cjr.liushiyuan@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Quantitative assessment of imaging biomarkers; This is the intervention arm. In this arm, the participants will be scanned with low-dose CT with pre-defined scanning parameters for two rounds (at baseline and in the second year). The screen-detected lung nodules will be managed according to the volume of the nodule. The quantitative assessment of imaging biomarkers of lung cancer, COPD and cardiovascular disease will be recorded.	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.
ACTIVE_COMPARATOR: Visual assessment of imaging biomarkers; This is the control arm. In this arm, the participants will be scanned with low-dose CT with routine scanning parameters used for lung cancer screening in the hospital for two rounds (at baseline and in the second year). The screen-detected lung nodules will be managed according to the diameter of the nodule. The imaging biomarkers related to lung cancer, COPD and cardiovascular disease will be visually assessed.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Investigators: Principal Investigator: Shiyuan Liu, Prof, Shanghai Changzheng Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Cardiovascular Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms
• Other Study ID Numbers: 2016YFE0103000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and publications of study results will be shared.
• IPD Sharing Time Frame: The study protocol will be available from January 2020. The study results will be available when published.
• IPD Sharing Access Criteria: All sharing will be accessed by publications, national and international scientific conference.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No