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

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

Interventions

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.

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).

Sponsors & Collaborators

• Shanghai Changzheng Hospital

  lead OTHER

Principal Investigators

• Shiyuan Liu, Prof · Shanghai Changzheng Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2021-09-30

Completion

2022-09-30

Countries

• China

Study Locations