中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500102288
最近更新日期： Date of Last Refreshed on：	2025-05-13 08:35:49
注册时间： Date of Registration：	2025-05-13 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	代谢组学联合蛋白组学检测探索肝脏炎癌转化过程中的血液标志物临床研究
Public title：	Clinical study of metabonomics combined with proteomic detection to explore blood markers in the process of liver inflammation and cancer transformation
注册题目简写：
English Acronym：
研究课题的正式科学名称：	代谢组学联合蛋白组学检测探索肝脏炎癌转化过程中的血液标志物临床研究
Scientific title：	Clinical study of metabonomics combined with proteomic detection to explore blood markers in the process of liver inflammation and cancer transformation
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	蔡妍	研究负责人：	孙涛
Applicant：	Cai Yan	Study leader：	Sun Tao
申请注册联系人电话： Applicant telephone：	+86 198 1850 8962	研究负责人电话： Study leader's telephone：	+86 182 5829 6259
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	2895844628@qq.com	研究负责人电子邮件： Study leader's E-mail：	326516058@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	浙江省杭州市滨江区滨文路548号浙江中医药大学	研究负责人通讯地址：	浙江省杭州市拱墅区潮王路318号
Applicant address：	No. 548 Binwen Road, Binjiang District, Hangzhou City, Zhejiang Chinese Medicine University	Study leader's address：	No. 318 Chaowang road, Gongshu district, Hangzhou, Zhejiang province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	浙江中医药大学
Applicant's institution：	Zhejiang Chinese Medicine University
研究负责人所在单位：	浙江中医药大学附属第二医院
Affiliation of the Leader：	The Second Affiliated Hospital of Zhejiang Chinese Medical University (Xinhua Hospital of Zhejiang Province)

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	浙中医大二院审2024研第053号-01	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	浙江中医药大学附属第二医院伦理委员会
Name of the ethic committee：	Ethics Review Committee of The Second Affiliated Hospital of Zhejiang Chinese Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-07-17 00:00:00
伦理委员会联系人：	黄延彪
Contact Name of the ethic committee：	Huang Yanbiao
伦理委员会联系地址：	浙江省杭州市拱墅区潮王路318号
Contact Address of the ethic committee：	No. 318 Chaowang road, Gongshu district, Hangzhou, Zhejiang province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 571 8808 9970	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

浙江中医药大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Zhejiang Chinese Medical University

研究实施负责（组长）单位地址：

浙江省杭州市拱墅区潮王路318号

Primary sponsor's address：

No. 318 Chaowang road, Gongshu district, Hangzhou, Zhejiang province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	浙江	市(区县)：	杭州市
Country：	China	Province：	Zhejiang	City：	Hangzhou
单位(医院)：	浙江中医药大学	具体地址：	浙江省杭州市滨江区滨文路548号
Institution hospital：	Zhejiang Chinese Medical University	Address：	No. 548 Binwen Road, Binjiang District, Hangzhou City, Zhejiang Province

经费或物资来源：

自筹

Source(s) of funding：

self-funding

研究疾病：

肝脏炎癌转化

Target disease：

Hepatitis and cancer transformation

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

病例对照研究

Study design：

Case-Control study

研究目的：

运用代谢组学及基因和蛋白组学技术，初步探索肝脏炎癌转化过程中（肝炎—肝纤维化—肝硬化—肝癌）的血液学标志物，为临床早发现、早诊断、早治疗提供依据。

Objectives of Study：

Metabonomics and gene and proteomics techniques were used to explore the hematological markers in the process of liver inflammation-liver fibrosis-liver cirrhosis-liver cancer, so as to provide basis for early clinical detection, early diagnosis and early treatment.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.(1) patients with hepatitis B and patients with non-alcoholic fatty liver disease in the liver disease group met the diagnostic criteria of the guidelines for Prevention and treatment of chronic Hepatitis B (2022 Edition). Inclusion criteria for patients with non-alcoholic fatty liver disease: in accordance with the diagnostic criteria of the guidelines for the Prevention and treatment of non-alcoholic Fatty liver Disease (updated 2018);
According to Metavir staging and liver transient elastic ultrasound, the patients were divided into two groups: non-fibrosis group and fibrosis group (including significant fibrosis and progressive fibrosis): 1). normal ALT with LSM < 6.0kPa or abnormal ALT with LSM < 7.4kPa, which belongs to non-fibrosis stage;2). abnormal ALT with LSM=9.4~12.4kPa, which belongs to the stage of significant fibrosis; 3) normal ALT with LSM=9.0~12.0kPa or abnormal ALT with LSM=12.4~17.0kPa belongs to the stage of progressive fibrosis. The rest should be classified to non-fibrotic stage or significant fibrotic stage according to the results of liver biopsy and blood indexes;
(2) Diagnostic criteria of patients with liver cirrhosis: in accordance with the diagnostic criteria of the guidelines for diagnosis and treatment of liver cirrhosis, the diagnostic criteria of compensatory stage were as follows: 1). pathological examination showed that intrahepatic tissue fibrosis was diffuse, internal false lobules were gradually formed, and the physiological structure of hepatic lobules was disordered. Hepatocyte nodule regeneration was found;2).Endoscopic examination revealed ectopic varices of stomach and digestive tract, excluding non-cirrhotic portal hypertension;3).B-ultrasonic examination of liver and spleen, liver hardness test (LSM), abdominal MRI, CT and other imaging examinations all showed liver cirrhosis;4). patients with lack of histology, endoscopy or imaging examination should meet at least two of the following four items: aspartate aminotransferase (AST) / platelet (PLT) ratio index > 2; PLT < 100 × 10^9 / L caused by no other causes; prothrombin time prolonged after thrombolysis or anticoagulant discontinuation for more than 7 days, or international standardized ratio of coagulation (INR) > 1.3 Albumin < 35g/L (excluding renal disease or malnutrition). On the contrary, it is the period of decompensation;
(3) Diagnostic criteria for patients with primary hepatocellular carcinoma: according to the diagnostic criteria in the 2023CSCO Code for diagnosis and treatment of Primary Hepatocellular carcinoma: 1). Clinical manifestations are liver cirrhosis, hepatomegaly, pain in the liver region, accompanied by progressive jaundice, weight loss, fever, fatigue, nausea, malnutrition and malignant disease; 2). two kinds of imaging examination showed characteristic space occupying lesions of liver cancer > 2cm;3) at the same time, the tumor marker alpha-fetoprotein (AFP) >= 400ug / kg, excluding pregnancy, hepatitis or metastatic liver cancer; 4) liver histopathological examination conformed to the diagnostic criteria of primary hepatocellular carcinoma (HCC); 5) according to the CSCO2023 guidelines for primary liver cancer, TNM stage belonged to early and middle stage (I, II, III); 6) there were complete data of anti-tumor treatment.
2.Control group: select healthy individuals who underwent physical examinations at the hospital during the same period, with normal liver function indicators.

排除标准：

（1）不符合上述纳入标准的患者；（2）其他肝病导致的肝炎、肝硬化、肝癌，如自身免疫性肝病、药物性肝损害、酒精性肝病等；（3）合并有严重心、肾及造血系统疾病，其它肿瘤疾病患者，精神疾病患者；（4）妊娠期妇女或哺乳妇女。对照组：肝炎、肝功能损伤及重大手术和疾病等病史。

Exclusion criteria：

1.(1) patients who do not meet the above inclusion criteria; (2) hepatitis, cirrhosis and liver cancer caused by other liver diseases, such as autoimmune liver disease, drug-induced liver damage, alcoholic liver disease, etc.; (3) complicated with severe heart, kidney and hematopoietic system diseases, patients with other tumor diseases, mental illness; (4) pregnant or lactating women. 2.Control group: history of hepatitis, liver function damage, major surgeries, and diseases.

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-08-04 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	肝病组	样本量：	100
Group：	Liver Disease	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	对照组	样本量：	100
Group：	Control	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	肝纤维化组	样本量：	100
Group：	Hepatic fibrosis	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	肝硬化代偿期	样本量：	100
Group：	compensatory Liver cirrhosis	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	肝硬化失代偿期	样本量：	100
Group：	decompensated Liver cirrhosis	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	肝癌组	样本量：	100
Group：	Liver Cancer	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江	市(区县)：	杭州
Country：	China	Province：	Zhejiang	City：	Hangzhou
单位(医院)：	浙江中医药大学附属第二医院	单位级别：	三甲
Institution hospital：	The Second Affiliated Hospital of Zhejiang Chinese Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	代谢组学	指标类型：	主要指标
Outcome：	Metabonomics	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	蛋白组学	指标类型：	主要指标
Outcome：	Proteomics	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总胆固醇	指标类型：	次要指标
Outcome：	Total cholesterol	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	甘油三酯	指标类型：	次要指标
Outcome：	Triglycerides	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	低密度脂蛋白胆固醇	指标类型：	次要指标
Outcome：	Low-density lipoprotein cholesterol	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	高密度脂蛋白胆固醇	指标类型：	次要指标
Outcome：	High-density lipoprotein cholesterol	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中医证候量表	指标类型：	次要指标
Outcome：	TCM syndrome scale	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	85	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	2028年12月31日通过邮件联系研究者询问
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Inquire by email to the researcher on December 31, 2028.
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	数据采集由纸质病历记录表组成，由两位主治以上医生填写，管理为我院内部的电子采集和管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The data acquisition consists of a paper medical record form, which is filled in by more than two attending doctors and managed by the electronic collection and management system in our hospital.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-05-13 08:35:21