Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study.
Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study.
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中国胆囊癌登记研究方案：中国胆囊癌研究组 (CRGGC) 研究
DOI：
10.1136/bmjopen-2020-038634
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发表时间：
2021-02-16
期刊：
影响因子：
2.9
通讯作者：
Liu Y
中科院分区：
文献类型：
--
作者：
Ren T;Li Y;Zhang X;Geng Y;Shao Z;Li M;Wu X;Wang XA;Liu F;Wu W;Shu Y;Bao R;Gong W;Dong P;Dang X;Liu C;Liu C;Sun B;Liu J;Wang L;Hong D;Qin R;Jiang X;Zhang X;Xu J;Jia J;Yang B;Li B;Dai C;Cao J;Cao H;Tao F;Zhang Z;Wang Y;Jin H;Cai H;Fei Z;Gu J;Han W;Feng X;Fang L;Zheng L;Zhu C;Wang K;Zhang X;Li X;Jin C;Qian Y;Cui Y;Xu Y;Wang X;Liu H;Hua Y;Liu C;Hao J;Wang C;Li Q;Li X;Liu J;Li M;Qiu Y;Wu B;Zheng J;Chen X;Zhu H;Hua K;Yan M;Wang P;Zang H;Ma X;Hong J;Liu Y
胆囊癌（GBC）是中国第六大最常见的胃肠道癌症，造成了重大的疾病负担。然而，中国人群中GBC的临床特征、治疗和预后尚无具有全国代表性的数据。中国胆囊癌研究组（CRGGC）研究是一项多中心回顾性登记队列研究。从2008年1月1日至2019年12月，通过审查中国28个省份76家三级和二级医院的电子病历，确定临床诊断的GBC患者。根据2019年国家综合癌症网络指南，病理和放射诊断为恶性肿瘤的患者，包括胆囊和胆囊管原位癌，符合条件。如果GBC是出院总结中的次要诊断，则排除患者。人口统计学特征、病史、体格检查结果、手术信息、病理资料、实验室检查结果和放射学报告将以标准化的病例报告形式收集。到2021年5月，将纳入约6000名GBC患者。临床随访数据将在每位患者最后一次因GBC入院后5年内更新。本研究旨在(1)描述中国GBC患者的临床特征，包括人口统计学、病理、治疗和预后；(2)评估GBC临床指南的依从性；(3)提高GBC的临床诊疗水平，为决策者提供参考。CRGGC方案已获得上海交通大学医学院新华医院伦理委员会批准（SHEC-C-2019-085）。本研究的所有结果将发表在同行评议的期刊上，并在相关会议上发表。NCT04140552 Pre-results。
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. 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. 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. NCT04140552, Pre-results.
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