肝癌生物样本库的标准化建立与信息化管理

Standardized establishment and informationized management of liver cancer biobank

目的建立一个小型的拥有标准化操作流程和信息化管理功能的肝癌生物样本库。方法根据纳排标准,在患者签署知情同意书基础上,收集2012年8月—2020年12月就诊于华中科技大学同济医学院附属同济医院肝脏外科的肝癌患者血液、组织和粪便样本,并按照全血、血清、冻存组织、石蜡包埋组织和粪便等不同样本的标准流程进行出入库管理,同时采集患者临床信息及其随访信息。通过随机抽取不同年份的肝癌及癌旁冷冻组织样本,检测总RNA的浓度和完整性,确保样本库冷冻样本保存质量。结果101个自然月共收集4190例肝癌手术患者样本,其中包括41718份冷冻组织样本、18950份石蜡包埋组织样本、24389份全血样本、20060份血清样本和5392份粪便样本。所收集肝癌患者的年龄范围是13~88岁,男性占比85.1%,乙型肝炎和肝硬化的比例分别是83.3%和73.5%。根据样本的收集、处理、保存、应用及信息化管理,制定出一份标准的操作流程(SOP)和一套电子数据采集系统(EDC)。从样本库随机抽取的18份冷冻组织样本中,其中16份样本RNA质量较高,可满足后续实验需求。结论建立了标准化和信息化的肝癌生物样本库,为肝癌基础研究提供了高质量的样本保障,能挖掘样本更多的研究价值。

Objective To establish a small liver cancer biobank with a standard operating procedure and the function of informationized management.Methods According to the inclusion and exclusion criteria,blood,tissue,and stool samples were collected from the patients with liver cancer who attended Liver Surgery Center,Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology,from August 2012 to December 2020 and signed the informed consent.In-and-out-of-storage management was performed based on the standard procedure for whole blood,serum,frozen tissue,paraffin-embedded tissue,and stool samples,and related clinical and follow-up data were collected.The frozen samples of liver cancer tissue and adjacent tissue in different years were randomly selected,and the concentration and completeness of total RNA were examined to ensure the quality of frozen samples stored in the biobank.Results The samples were collected from 4190 liver cancer patients who underwent surgery within a period of 101 natural months,and there were 41718 frozen tissue samples,18950 paraffin-embedded tissue samples,24389 whole blood samples,20060 serum samples,and 5392 stool samples.The liver cancer patients had an age range of 13-88 years,and male patients accounted for 85.1%.The patients with hepatitis B accounted for 83.3%,and those with liver cirrhosis accounted for 73.5%.A standard operating procedure and an electronic data capture system were developed according to the collection,processing,storage,application,and informationized management of samples.Among the 18 frozen tissue samples randomly selected from the biobank,16 samples had high RNA quality,which could meet the requirements of subsequent experiments.Conclusion A standardized and informationized biobank has been established for liver cancer,which provides high-quality samples for the basic research on liver cancer and helps to explore the research value of samples.