Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma.
Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma.
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DOI：
10.1186/1471-230x-11-53
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发表时间：
2011-05-12
影响因子：
2.4
通讯作者：
Qiao YL
中科院分区：
文献类型：
--
作者：
Chen M;Therneau T;Orsini LS;Qiao YL
全球超过50%的肝细胞癌病例发生在中国，这种恶性肿瘤目前是中国城市癌症死亡的第二大原因，也是农村地区的主要原因。尽管近年来中国在肝细胞癌的控制和管理方面取得了进展，但这种疾病仍然是一个主要的卫生保健问题。全球HCC BRIDGE研究旨在评估真实世界临床实践中肝细胞癌治疗使用的模式和相关结局，最近已扩展为中国的国家研究，可以对这个重要国家的肝细胞癌进行详细分析。全球HCC BRIDGE研究是一项多地区纵向队列试验，纳入了2005年1月1日至2011年6月30日期间新诊断为肝细胞癌的患者，这些患者正在亚太、欧洲和北美地区的研究中心接受肝细胞癌治疗。HCC BRIDGE中国国家研究包括在中国大陆进行的全球HCC BRIDGE研究的一部分。将从肝细胞癌诊断时间（2005年1月1日之后）至死亡时间或2011年12月31日（以先发生者为准）对患者进行随访。将收集关于人口统计学/临床特征、相关实验室检查值、肝细胞癌/基础肝病治疗、肿瘤缓解、不良事件、住院和总生存期的数据。主要研究终点是总生存期;次要终点是疾病进展、治疗限制性不良事件和治疗失败。在撰写本报告时，中国所有7个传统地区（北方、东北、东部、南方、西南、西北和中部）的15个地点已被选中参加。中国国家研究的预期研究人群约为9000例患者。HCC BRIDGE中国国家研究是中国首个具有地域代表性的肝细胞癌研究，其结果将有助于了解治疗使用模式和相关临床结局，并将提供关于这个重要国家肝细胞癌持续未满足需求的进一步信息。
More than 50% of the worldwide cases of hepatocellular carcinoma occur in China, and this malignancy currently represents the country's second leading cause of cancer death in cities and the leading cause in rural areas. Despite recent advances in the control and management of hepatocellular carcinoma within China, this disease remains a major health care issue. The global HCC BRIDGE study, designed to assess patterns of hepatocellular carcinoma therapy use and associated outcomes across real-world clinical practice, has recently been expanded as a national study in China, allowing a detailed analysis of hepatocellular carcinoma in this important country. The global HCC BRIDGE study is a multiregional longitudinal cohort trial including patients newly diagnosed with hepatocellular carcinoma between January 1, 2005, and June 30, 2011, who are receiving treatment for hepatocellular carcinoma via sites in the Asia-Pacific, European, and North American regions. The HCC BRIDGE China national study comprises the portion of the global HCC BRIDGE study conducted within mainland China. Patients will be followed from time of diagnosis of hepatocellular carcinoma (post-January 1, 2005) to time of death or December 31, 2011, whichever comes first. Data will be collected on demographic/clinical characteristics, relevant laboratory values, hepatocellular carcinoma/underlying liver disease treatment, tumor response, adverse events, hospitalizations, and overall survival. The primary study end point is overall survival; secondary end points are disease progression, treatment-limiting adverse events, and treatment failure. At the time of writing, 15 sites have selected for participation across all 7 traditional regions of China (North, North-East, East, South, South-West, North-West, and Central). The anticipated study population from the China national study is approximately 9000 patients. Findings from the HCC BRIDGE China national study, the first geographically representative study of hepatocellular carcinoma in China, will contribute to the understanding of patterns of therapy use and related clinical outcomes and will provide further information on continuing unmet needs for hepatocellular carcinoma throughout this important country.