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

NCT03988322 | Unknown DMC

• 1 other identifier: 2016YFE0103000
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Mass Screening; Chronic Obstructive Pulmonary Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Quantitative assessment of imaging biomarkers

EXPERIMENTAL

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

Visual assessment of imaging biomarkers

ACTIVE COMPARATOR

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

Interventions

Low-dose CT screening with quantitative assessment and management of imaging biomarkers OTHER

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.

Quantitative assessment of imaging biomarkers

Low-dose CT screening with visual assessment and management of imaging biomarkers OTHER

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).

Visual assessment of imaging biomarkers

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women will be excluded.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32151538 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiyuan Liu, Prof

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyuan Liu, Prof

CONTACT

021-81886609; cjr.liushiyuan@vip.163.com

Qiong Li

CONTACT

021-81886011; 925454346@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 17, 2019
• Study Start: September 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be available from January 2020. The study results will be available when published.
• Access Criteria: All sharing will be accessed by publications, national and international scientific conference.

Locations

CN (1)