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Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study.


ABSTRACT:

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.

SUBMITTER: Ren T 

PROVIDER: S-EPMC7888310 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study.

Ren Tai T   Li Yongsheng Y   Zhang Xi X   Geng Yajun Y   Shao Ziyu Z   Li Maolan M   Wu Xiangsong X   Wang Xu-An XA   Liu Fatao F   Wu Wenguang W   Shu Yijun Y   Bao Runfa R   Gong Wei W   Dong Ping P   Dang Xueyi X   Liu Chang C   Liu Changjun C   Sun Bei B   Liu Jun J   Wang Lin L   Hong Defei D   Qin Renyi R   Jiang Xiaoqing X   Zhang Xuewen X   Xu Junmin J   Jia Jianguang J   Yang Bo B   Li Bing B   Dai Chaoliu C   Cao Jingyu J   Cao Hong H   Tao Feng F   Zhang Zaiyang Z   Wang Yi Y   Jin Huihan H   Cai Hongyu H   Fei Zhewei Z   Gu Jianfeng J   Han Wei W   Feng Xuedong X   Fang Lu L   Zheng Linhui L   Zhu Chunfu C   Wang Kunhua K   Zhang Xueli X   Li Xiaoyong X   Jin Chong C   Qian Yeben Y   Cui Yunfu Y   Xu Yuzhen Y   Wang Xiang X   Liu Houbao H   Hua Yawei Y   Liu Chao C   Hao Jihui J   Wang Chuanlei C   Li Qiyun Q   Li Xun X   Liu Jiansheng J   Li Mingzhang M   Qiu Yudong Y   Wu Buqiang B   Zheng Jinfang J   Chen Xiaoliang X   Zhu Haihong H   Hua Kejun K   Yan Maolin M   Wang Peng P   Zang Hong H   Ma Xiaoming X   Hong Jian J   Liu Yingbin Y  

BMJ open 20210216 2


<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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  ...[more]

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