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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

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

Treatments: Other: Low-dose CT screening with visual assessment and management of imaging biomarkers; Other: Low-dose CT screening with quantitative assessment and management of imaging biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT03988322

2016YFE0103000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 2 patient groups

Quantitative assessment of imaging biomarkers

Experimental group

Description:

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.

Treatment:

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

Visual assessment of imaging biomarkers

Active Comparator group

Description:

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.

Treatment:

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