TY - JOUR
T1 - Design and rationale of the HCC BRIDGE study in China
T2 - A longitudinal, multicenter cohort trial in hepatocellular carcinoma
AU - Chen, Minshan
AU - Therneau, Terry
AU - Orsini, Lucinda S.
AU - Qiao, You Lin
N1 - Funding Information:
The authors would like to acknowledge the essential contribution of the other clinical investigators participating in the HCC BRIDGE China national study, as follows: Lequn Li, JiJin Jiang, Guohong Han, Enshua Xiao, Lvnan Yan, Yuxian Bai, and Ping Zhao. The authors would also like to thank Li Ling (EXCEL); Lindsay Dudgeon (Outcome Sciences, Inc.); and Gabriella Cucinotta, Hannah Chen, Helena Zhu, and Wenjun Xiao (Bristol-Myers Squibb) for various study and data management activities. During the development of this manuscript, editorial support was provided by Richard Daniel, PhD, of PAREXEL, and was funded by Bristol-Myers Squibb. The HCC BRIDGE study is supported by research funding from Bristol-Myers Squibb (Study No. CA182023).
PY - 2011/5/12
Y1 - 2011/5/12
N2 - Background: 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.Methods/Design: 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.Results: 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.Discussion: 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.
AB - Background: 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.Methods/Design: 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.Results: 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.Discussion: 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.
UR - http://www.scopus.com/inward/record.url?scp=79955829415&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79955829415&partnerID=8YFLogxK
U2 - 10.1186/1471-230X-11-53
DO - 10.1186/1471-230X-11-53
M3 - Article
C2 - 21569429
AN - SCOPUS:79955829415
SN - 1471-230X
VL - 11
JO - BMC Gastroenterology
JF - BMC Gastroenterology
M1 - 53
ER -