Methods of computed tomography screening and management of lung cancer in Tianjin: design of a population-based cohort study
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摘要
Objective: European lung cancer screening studies using computed tomography(CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time(VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.Methods: This study has a population-based, prospective cohort design and includes 4000 participants from the Hexi district of Tianjin, China. Participants will undergo low-dose chest CT at baseline and after 1 year. Initially, detected lung nodules will be evaluated for diameter and managed according to a routine diameter-based protocol(Clinical Practice Guideline in Oncology for Lung Cancer Screening, Version 2.2018). Subsequently, lung nodules will be evaluated for volume and management will be simulated according to a volume-based protocol and VDT(a European lung nodule management protocol). Participants will be followed up for 4 years to evaluate lung cancer incidence and mortality. The primary outcome is the diagnostic performance of the European volume-based protocol compared to diameter-based management regarding lung nodules detected using low-dose CT.Results: The diagnostic performance of volume-and diameter-based management for lung nodules in a Chinese population will be estimated and compared.Conclusions: Through the study, we expect to improve the management of lung nodules and early detection of lung cancer in Chinese populations.
Objective: European lung cancer screening studies using computed tomography(CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time(VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.Methods: This study has a population-based, prospective cohort design and includes 4000 participants from the Hexi district of Tianjin, China. Participants will undergo low-dose chest CT at baseline and after 1 year. Initially, detected lung nodules will be evaluated for diameter and managed according to a routine diameter-based protocol(Clinical Practice Guideline in Oncology for Lung Cancer Screening, Version 2.2018). Subsequently, lung nodules will be evaluated for volume and management will be simulated according to a volume-based protocol and VDT(a European lung nodule management protocol). Participants will be followed up for 4 years to evaluate lung cancer incidence and mortality. The primary outcome is the diagnostic performance of the European volume-based protocol compared to diameter-based management regarding lung nodules detected using low-dose CT.Results: The diagnostic performance of volume-and diameter-based management for lung nodules in a Chinese population will be estimated and compared.Conclusions: Through the study, we expect to improve the management of lung nodules and early detection of lung cancer in Chinese populations.
Objective: European lung cancer screening studies using computed tomography(CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time(VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.Methods: This study has a population-based, prospective cohort design and includes 4000 participants from the Hexi district of Tianjin, China. Participants will undergo low-dose chest CT at baseline and after 1 year. Initially, detected lung nodules will be evaluated for diameter and managed according to a routine diameter-based protocol(Clinical Practice Guideline in Oncology for Lung Cancer Screening, Version 2.2018). Subsequently, lung nodules will be evaluated for volume and management will be simulated according to a volume-based protocol and VDT(a European lung nodule management protocol). Participants will be followed up for 4 years to evaluate lung cancer incidence and mortality. The primary outcome is the diagnostic performance of the European volume-based protocol compared to diameter-based management regarding lung nodules detected using low-dose CT.Results: The diagnostic performance of volume-and diameter-based management for lung nodules in a Chinese population will be estimated and compared.Conclusions: Through the study, we expect to improve the management of lung nodules and early detection of lung cancer in Chinese populations.
引文
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14.Walter JE,Heuvelmans MA,de Jong PA,Vliegenthart R,van Ooijen PMA,Peters RB,et al.Occurrence and lung cancer probability of new solid nodules at incidence screening with lowdose CT:analysis of data from the randomised,controlled NELSON trial.Lancet Oncol.2016;17:907-16.
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22.Kakinuma R,Noguchi M,Ashizawa K,Kuriyama K,Maeshima AM,Koizumi N,et al.Natural history of pulmonary subsolid nodules:a prospective multicenter study.J Thorac Oncol.2016;11:1012-28.
23.Liu YA,Sun H,Zhou F,Su CX,Gao GH,Ren SX,et al.Imaging features of TSCT predict the classification of pulmonary preinvasive lesion,minimally and invasive adenocarcinoma presented as ground glass nodules.Lung Cancer.2017;108:192-7.
24.Song YS,Park CM,Park SJ,Lee SM,Jeon YK,Goo JM.Volume and mass doubling times of persistent pulmonary subsolid nodules detected in patients without known malignancy.Radiology.2014;273:276-84.
25.EQ-5D.Available from:https://euroqol.org/eq-5d-instruments/eq-5d-3l-available-modes-of-administration/[Accessed December 21,2018].
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27.Cardiothoracic Group of Radiology Branch in Chinese Medical Association.Chinese expert consensus on the Low-dose spiral CTlung cancer screening(in Chinese).Chin J Radiol.2015;49:328-35.
28.Bach PB,Mirkin JN,Oliver TK,Azzoli CG,Berry D,Brawley OW,et al.Benefits and harms of CT screening for lung cancer:a systematic review.JAMA.2012;307:2418-29.
29.The State Council,The People’s Republic of China.The general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the examination and approval system and encouraging the innovation of pharmaceutical and medical devices(in Chinese).,Available from:http://www.gov.cn/xinwen/2017-10/08/content_5230105.htm[Accessed December 21,2018].
2.Chen WQ,Zheng RS,Baade PD,Zhang SW,Zeng HM,Bray F,et al.Cancer statistics in China,2015.CA Cancer J Clin.2016;66:115-32.
3.Chang S,Dai M,Ren JS,Chen YH,Guo LW.Estimates and prediction on incidence,mortality and prevalence of lung cancer in China in 2008.Chin J Epidemiol.2012;33:391-4.
4.Ferlay J,Shin HR,Bray F,Forman D,Mathers C,Parkin DM.Estimates of worldwide burden of cancer in 2008:GLOBOCAN2008.Int J Cancer.2010;127:2893-917.
5.Wang JB,Fan YG,Jiang Y,Li P,Xiao HJ,Chen WQ,et al.Attributable causes of lung cancer incidence and mortality in China.Thorac Cancer.2011;2:156-63.
6.Chinese Center for Disease Control and Prevention.2015 China Adult Tobacco Survey Report(in Chinese).,Available from:http://www.chinacdc.cn/gwswxx/kyb/201512/t20151228_123960.ht ml.[Accessed December 21,2018].
7.Chen WQ,Zheng RS,Zeng HM,Zhang SW.Epidemiology of lung cancer in China.Thorac Cancer.2015;6:209-15.
8.Shao Q,Li JB,Li FX,Wang SZ,Wang W,Liu SS,et al.Clinical investigation into the initial diagnosis and treatment of 1,168 lung cancer patients.Oncol Lett.2015;9:563-8.
9.Wei SH,Tian JT,Song XP,Wu BQ,Liu LM.Causes of death and competing risk analysis of the associated factors for non-small cell lung cancer using the Surveillance,Epidemiology,and End Results database.J Cancer Res Clin Oncol.2018;144:145-55.
10.Yang P,Allen MS,Aubry MC,Wampfler JA,Marks RS,Edell ES,et al.Clinical features of 5,628 primary lung cancer patients:experience at Mayo Clinic from 1997 to 2003.Chest.2005;128:452-62.
11.Oudkerk M,Devaraj A,Vliegenthart R,Henzler T,Prosch H,Heussel CP,et al.European position statement on lung cancer screening.Lancet Oncol.2017;18:e754-66.
12.National Lung Screening Trial Research Team.Reduced lungcancer mortality with low-dose computed tomographic screening.N Engl J Med.2011;365:395-409.
13.Horeweg N,van Rosmalen J,Heuvelmans MA,van der Aalst CM,Vliegenthart R,Scholten ET,et al.Lung cancer probability in patients with CT-detected pulmonary nodules:a prespecified analysis of data from the NELSON trial of low-dose CT screening.Lancet Oncol.2014;15:1332-41.
14.Walter JE,Heuvelmans MA,de Jong PA,Vliegenthart R,van Ooijen PMA,Peters RB,et al.Occurrence and lung cancer probability of new solid nodules at incidence screening with lowdose CT:analysis of data from the randomised,controlled NELSON trial.Lancet Oncol.2016;17:907-16.
15.Wang ZX,Han W,Zhang WW,Xue F,Wang YY,Hu YD,et al.Mortality outcomes of low-dose computed tomography screening for lung cancer in urban China:a decision analysis and implications for practice.Chin J Cancer.2017;36:57.
16.NCCN Clinical Practice Guidelines in Oncology:Lung Cancer Screening(version 2.2018).Available from:https://www.nccn.org/store/login/login.aspx?Return URL=https://w ww.nccn.org/professionals/physician_gls/pdf/lung_screening.pdf.[Accessed December 21,2018].
17.Mac Mahon H,Austin JHM,Gamsu G,Herold CJ,Jett JR,Naidich DP,et al.Guidelines for management of small pulmonary nodules detected on CT scans:a statement from the Fleischner Society.Radiology.2005;237:395-400.
18.Zhou QH,Fan YG,Bu H,Wang Y,Wu N,Huang YC,et al.China national lung cancer screening guideline with low-dose computed tomography(2015 version).Thorac Cancer.2015;6:812-8.
19.van Klaveren RJ,Oudkerk M,Prokop M,Scholten ET,Nackaerts K,Vernhout R,et al.Management of lung nodules detected by volume CT scanning.N Engl J Med.2009;361:2221-9.
20.Field JK,Marcus MW,Oudkerk M.Risk assessment in relation to the detection of small pulmonary nodules.Transl Lung Cancer Res.2017;6:35-41.
21.Important grant for collaboration in research on early detection of lung cancer,COPD and cardiovascular diseases.https://www.rug.nl/news/2016/11/grote-subsidie-voorsamenwerking-in-onderzoek-vroege-opsporing-longkanker_-copd-en-hart--en-vaatziekten?lang=en.[Accessed December 21,2018]
22.Kakinuma R,Noguchi M,Ashizawa K,Kuriyama K,Maeshima AM,Koizumi N,et al.Natural history of pulmonary subsolid nodules:a prospective multicenter study.J Thorac Oncol.2016;11:1012-28.
23.Liu YA,Sun H,Zhou F,Su CX,Gao GH,Ren SX,et al.Imaging features of TSCT predict the classification of pulmonary preinvasive lesion,minimally and invasive adenocarcinoma presented as ground glass nodules.Lung Cancer.2017;108:192-7.
24.Song YS,Park CM,Park SJ,Lee SM,Jeon YK,Goo JM.Volume and mass doubling times of persistent pulmonary subsolid nodules detected in patients without known malignancy.Radiology.2014;273:276-84.
25.EQ-5D.Available from:https://euroqol.org/eq-5d-instruments/eq-5d-3l-available-modes-of-administration/[Accessed December 21,2018].
26.Liu GG,Wu HY,Li MH,Gao C,Luo N.Chinese time trade-off values for EQ-5D health states.Value Health.2014;17:597-604.
27.Cardiothoracic Group of Radiology Branch in Chinese Medical Association.Chinese expert consensus on the Low-dose spiral CTlung cancer screening(in Chinese).Chin J Radiol.2015;49:328-35.
28.Bach PB,Mirkin JN,Oliver TK,Azzoli CG,Berry D,Brawley OW,et al.Benefits and harms of CT screening for lung cancer:a systematic review.JAMA.2012;307:2418-29.
29.The State Council,The People’s Republic of China.The general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the examination and approval system and encouraging the innovation of pharmaceutical and medical devices(in Chinese).,Available from:http://www.gov.cn/xinwen/2017-10/08/content_5230105.htm[Accessed December 21,2018].
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