Design of the Texas Hepatocellular Carcinoma Consortium Cohort Study

Design of the Texas Hepatocellular Carcinoma Consortium Cohort Study
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DOI:
10.14309/ajg.0000000000000068
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发表时间:
2019-03-01
影响因子:
9.8
通讯作者:
El-Serag, Hashem B.
El-Serag, Hashem B.
中科院分区:
医学1区
文献类型:
--
作者:
Feng, Ziding;Marrero, Jorge A.;El-Serag, Hashem B.

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结论:德克萨斯州肝细胞癌联盟队列研究调查肝细胞癌(HCC)的危险因素和肝硬化患者早期HCC检测的生物标志物。方法:来自德克萨斯州3个城市的5个临床中心招募了肝硬化成人患者,目标为5,000例患者。临床病史,危险因素问卷调查,肝脏成像,实验室数据,血液样本收集在登记和在每个6个月的随访vision.RESULTS:主要结果是肝癌的发展。生物标志物进行了测试,在银行的血液样本使用前瞻性标本采集,回顾性盲评价design.CONCLUSIONS:我们描述了研究设计,合格标准,招聘,研究核心,样本量和分析考虑。
OBJECTIVES:The Texas Hepatocellular Carcinoma Consortium cohort study investigates risk factors of hepatocellular carcinoma (HCC) and biomarkers for early HCC detection in patients with liver cirrhosis.METHODS:Adult patients with liver cirrhosis are enrolled at 5 clinical centers from 3 cities in Texas, with a target of 5,000 patients. Clinical history, risk factor questionnaires, liver imaging, laboratory data, and blood samples were collected at enrollment and at each 6-month follow-up visit.RESULTS:The primary outcome was the development of HCC. Biomarkers were tested in banked blood samples using prospective specimen collection, retrospective blinded evaluation design.CONCLUSIONS:We describe study design, eligibility criteria, recruitment, study cores, and sample size and analysis considerations.