Introduction Gallbladder cancer (GBC), the sixth most common gastrointestinal tract cancer, poses a significant disease burden in China. However, no national representative data are available on the clinical characteristics, treatment and prognosis of GBC in the Chinese population. Methods and analysis The Chinese Research Group of Gallbladder Cancer (CRGGC) study is a multicentre retrospective registry cohort study. Clinically diagnosed patient with GBC will be identified from 1 January 2008 to December, 2019, by reviewing the electronic medical records from 76 tertiary and secondary hospitals across 28 provinces in China. Patients with pathological and radiological diagnoses of malignancy, including cancer in situ, from the gallbladder and cystic duct are eligible, according to the National Comprehensive Cancer Network 2019 guidelines. Patients will be excluded if GBC is the secondary diagnosis in the discharge summary. The demographic characteristics, medical history, physical examination results, surgery information, pathological data, laboratory examination results and radiology reports will be collected in a standardised case report form. By May 2021, approximately 6000 patient with GBC will be included. The clinical follow-up data will be updated until 5 years after the last admission for GBC of each patient. The study aimed (1) to depict the clinical characteristics, including demographics, pathology, treatment and prognosis of patient with GBC in China; (2) to evaluate the adherence to clinical guidelines of GBC and (3) to improve clinical practice for diagnosing and treating GBC and provide references for policy-makers. Ethics and dissemination The protocol of the CRGGC has been approved by the Committee for Ethics of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (SHEC-C-2019-085). All results of this study will be published in peer-reviewed journals and presented at relevant conferences. Trial registration number NCT04140552, Pre-results.
基金:
National Natural Science Foundation of China [31620103910, 81874181, 91940305]; Emerging Frontier Programme of Hospital Development Centre [SHDC12018107]; Key Programme of Shanghai Science and Technology Commission [YDZX20193100004049]; Shanghai Key Laboratory of Biliary Tract Disease Research Foundation [17DZ2260200]; Shanghai Artificial Intelligence Innovation and Development Project (2019, Project of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine); Multi-Centre Clinical Research Project of Shanghai Jiao Tong University School of Medicine [DLY201507]; Translational Medicine Innovation Fund of Shanghai Jiao Tong University School of Medicine [15ZH4003]
第一作者单位:[1]Shanghai Jiao Tong Univ, Dept Gen Surg, Sch Med, Dept Gen Surg,Xinhua Hosp, Shanghai, Peoples R China[2]Shanghai Key Lab Biliary Tract Dis Res, Shanghai, Peoples R China
通讯作者:
通讯机构:[2]Shanghai Key Lab Biliary Tract Dis Res, Shanghai, Peoples R China[3]Shanghai Jiao Tong Univ, Dept Biliary Pancreat Surg, Sch Med, Affiliated Renji Hosp, Shanghai, Peoples R China
推荐引用方式(GB/T 7714):
Ren Tai,Li Yongsheng,Zhang Xi,et al.Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study[J].BMJ OPEN.2021,11(2):doi:10.1136/bmjopen-2020-038634.
APA:
Ren, Tai,Li, Yongsheng,Zhang, Xi,Geng, Yajun,Shao, Ziyu...&Liu, Yingbin.(2021).Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study.BMJ OPEN,11,(2)
MLA:
Ren, Tai,et al."Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study".BMJ OPEN 11..2(2021)