Yihui Du1, Qiong Li2, Grigory Sidorenkov1, Marleen Vonder1, Jiali Cai2, Geertruida H de Bock1, Yu Guan2, Yi Xia2, Xiuxiu Zhou2, Di Zhang2, Mieneke Rook3, Rozemarijn Vliegenthart4, Marjolein A Heuvelmans5, Monique D Dorrius4, P M A van Ooijen6, Harry J M Groen7, Pim van der Harst8, Yi Xiao2, Zhaoxiang Ye9, Xueqian Xie10, Wenjing Wang11, Matthijs Oudkerk12, Li Fan2, Shiyuan Liu13. 1. University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, The Netherlands. 2. Changzheng Hospital, Second Military Medical University, Department of Radiology, No. 415 Fengyang Rd, Shanghai 200003, The People's Republic of China. 3. University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, The Netherlands; Martini Hospital, Department of Radiology, Groningen, The Netherlands. 4. University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, The Netherlands. 5. University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, The Netherlands; Medisch Spectrum Twente, Department of Pulmonology, Enschede, The Netherlands. 6. Department of Radiation Therapy, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 7. University of Groningen, University Medical Centre Groningen, Department of Pulmonary Diseases, Groningen, The Netherlands. 8. University of Groningen, University Medical Centre Groningen, Department of Cardiology, Groningen, The Netherlands. 9. Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, The People's Republic of China. 10. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Department of Radiology, Shanghai, The People's Republic of China. 11. Shanghai Center for Disease Control and Prevention, Department of Epidemiology, Shanghai, The People's Republic of China. 12. University of Groningen, Groningen, The Netherlands. 13. Changzheng Hospital, Second Military Medical University, Department of Radiology, No. 415 Fengyang Rd, Shanghai 200003, The People's Republic of China. Electronic address: liushiyuan@smmu.edu.cn.
Abstract
RATIONALE AND OBJECTIVES: To describe the rational and design of a population-based comparative study. The objective of the study 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 chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. MATERIALS AND METHODS: A population-based comparative study is being performed, including 10,000 asymptomatic participants between 40 and 74 years old from Shanghai urban population. Participants in the intervention group undergo a low-dose chest and cardiac CT scan at baseline and 1 year later, and are managed according to NELCIN-B3 protocol. Participants in the control group undergo a low-dose chest CT scan according to the routine CT protocol and are managed according to the clinical practice. Epidemiological data are collected through questionnaires. In the fourth year from baseline, the diagnosis of the three diseases will be collected. RESULTS: The unnecessary referral rate will be compared between NELCIN-B3 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. CONCLUSION: We expect that the quantitative assessment of the CT imaging biomarkers will reduce the number of unnecessary referrals for early detected lung nodules, and will improve the early detection of COPD and CVD in a Chinese urban population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03988322. Registered on 14 June 2019.
RATIONALE AND OBJECTIVES: To describe the rational and design of a population-based comparative study. The objective of the study 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 chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. MATERIALS AND METHODS: A population-based comparative study is being performed, including 10,000 asymptomatic participants between 40 and 74 years old from Shanghai urban population. Participants in the intervention group undergo a low-dose chest and cardiac CT scan at baseline and 1 year later, and are managed according to NELCIN-B3 protocol. Participants in the control group undergo a low-dose chest CT scan according to the routine CT protocol and are managed according to the clinical practice. Epidemiological data are collected through questionnaires. In the fourth year from baseline, the diagnosis of the three diseases will be collected. RESULTS: The unnecessary referral rate will be compared between NELCIN-B3 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. CONCLUSION: We expect that the quantitative assessment of the CT imaging biomarkers will reduce the number of unnecessary referrals for early detected lung nodules, and will improve the early detection of COPD and CVD in a Chinese urban population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03988322. Registered on 14 June 2019.
Authors: Aleksandra Undrunas; Piotr Kasprzyk; Aleksandra Rajca; Krzysztof Kuziemski; Witold Rzyman; Tomasz Zdrojewski Journal: BMJ Open Date: 2022-04-11 Impact factor: 2.692