ChiCTR2400089021 版本V1.0 版本创建时间2024/08/30 11:40:35 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400089021 

最近更新日期：

Date of Last Refreshed on：

 2024-08-30 11:40:09 

注册时间：

Date of Registration：

 2024-08-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

BCAR3及相关基因的表达和调控在非酒精性脂肪肝中的作用和机制研究

Public title：

The role and mechanism of expression and regulation of BCAR3 and related genes in non-alcoholic fatty liver disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

BCAR3及相关基因的表达和调控在非酒精性脂肪肝中的作用和机制研究

Scientific title：

The role and mechanism of expression and regulation of BCAR3 and related genes in non-alcoholic fatty liver disease

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：

彭邦剑 

研究负责人：

张志 

Applicant：

Bangjian Peng 

Study leader：

Zhi Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 136 3030 8575

研究负责人电话：

Study leader's
telephone：

+86 185 8873 4033

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：

 xiaojianpeng2012@163.com

研究负责人电子邮件：

Study leader's E-mail：

 mshijizhang@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 南方医科大学第五附属医院

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：

广东省广州市从化区从城大道566号

研究负责人通讯地址：

广东省广州市从化区从城大道566号

Applicant address：

566 Congcheng Avenue, Conghua District, Guangzhou City, Guangdong Province

Study leader's address：

566 Congcheng Avenue, Conghua District, Guangzhou City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

 510900

研究负责人邮政编码：

Study leader's postcode：

 510900

申请人所在单位：

南方医科大学第五附属医院

Applicant's institution：

The Fifth Affiliated Hospital of Southern Medical University

研究负责人所在单位：

南方医科大学第五附属医院

Affiliation of the Leader：

The Fifth Affiliated Hospital of Southern Medical University

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：

 2024-GDWK-K-001

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：

南方医科大学第五附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Fifth Affiliated Hospital of Southern Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-13 00:00:00

伦理委员会联系人：

栗子涵

Contact Name of the ethic committee：

Zihan Li

伦理委员会联系地址：

广东省广州市从化区从城大道566号

Contact Address of the ethic committee：

566 Congcheng Avenue, Conghua District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 6223 6058

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：

南方医科大学第五附属医院

Primary sponsor：

The Fifth Affiliated Hospital of Southern Medical University

研究实施负责（组长）单位地址：

广东省广州市从化区从城大道566号

Primary sponsor's address：

566 Congcheng Avenue, Conghua District, Guangzhou City, Guangdong 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)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou City

单位(医院)：

南方医科大学第五附属医院

具体地址：

广东省广州市从化区从城大道566号

Institution
hospital：

The Fifth Affiliated Hospital of Southern Medical University

Address：

566 Congcheng Avenue, Conghua District, Guangzhou City, Guangdong Province

经费或物资来源：

课题组经费

Source(s) of funding：

Funding for the Research Group

研究疾病：

非酒精性脂肪肝  

Target disease：

Non-alcoholic fatty liver disease

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

①主要目的: 收集临床肝胆手术后废弃的肝标本，检测 METTL3、BCAR3、USP11、TRAF3 的表达，分析METTL3/BCAR3、USP11/TRAF3、BCAR3/TRAF3 之间的表达相关性，明确METTL3-BCAR3-USP11-TRAF3 信号轴的临床意义以及 BCAR3 的预后意义。 ②次要目的：通过本项目的开展，希望可以为分子靶点的转化应用奠定理论基础，可以为临床上 NASH 的诊疗提供潜在的分子标志物和潜在的治疗靶点。  

Objectives of Study：

① Main purpose: To collect discarded liver specimens after clinical liver and gallbladder surgery and detect METTL3 Expression of BCAR3, USP11, and TRAF3, analysis of METTL3/BCAR3 The expression correlation between USP11/TRAF3 and BCAR3/TRAF3, clarifying the clinical significance of the METTL3-BCAR3-USP11-TRAF3 signaling axis and the prognostic significance of BCAR3. ② Secondary objective: Through the implementation of this project, we hope to lay a theoretical foundation for the transformation and application of molecular targets, and provide potential molecular markers and therapeutic targets for the clinical diagnosis and treatment of NASH.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①自愿签署知情同意书； ②年龄≧18岁，≤60岁； ③按照治疗医生的判断因非脂肪肝疾病需要行肝胆手术的患者，同时要求术后废弃肝组织标本有可供本实验需要的体积，大小至少2*2*2cm。 ④实验组人选标准：参照《AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease，2023版》和《脂肪性肝病诊疗规范化的专家建议（2019年修订版）》等进行诊断为NAFLD的患者，并且术后病理证实为脂肪肝，纳入为实验组。 ⑤对照组入选标准：术后病理证实没有脂肪肝的患者纳入为对照组。

Inclusion criteria

① Voluntary signing of informed consent form; ② Age ≥ 18 years old, ≤ 60 years old; ③ According to the judgment of the treating physician, patients who require liver and gallbladder surgery due to non fatty liver diseases are required to have a volume of at least 2 * 2 * 2cm of discarded liver tissue samples available for this experiment after surgery. ④ Selection criteria for the experimental group: Patients diagnosed with NAFLD according to the AASLD Practice Guidance on the Clinical Assessment and Management of Nonalcoholic Fatty Liver Disease, 2023 Edition, and Expert Recommendations for Standardized Diagnosis and Treatment of Fatty Liver Disease (Revised 2019 Edition), who have been confirmed to have fatty liver by postoperative pathology, will be included in the experimental group. ⑤ Selection criteria for the control group: Patients confirmed by postoperative pathology to have no fatty liver were included in the control group.

排除标准：

①缺乏必要的人口学指标、身体测量学指标、检验学指标等。 ②缺乏必要的既往史及用药史。 ③饮酒或过量饮酒史：过去 12 个月每周饮用乙醇（酒精）男性标准饮酒量每周21杯，女性标准饮酒量每周14杯 。 ④应用乙胺碘呋酮、甲氨蝶呤、他莫昔芬、糖皮质激素等药物。 ⑤基因3型丙型肝炎病毒感染、肝豆状核变性、自身免疫性肝炎、全胃肠外营养、乏β脂蛋白血症、先天性脂质萎缩症、乳糜泻等可以导致脂肪肝的特定疾病。 ⑥合并其它病毒性肝炎、肿瘤或其它严重系统性疾病的患者。 ⑦限制或无民事行为能力人。 ⑧妊娠期患者。

Exclusion criteria：

① Lack of necessary demographic indicators, physical measurement indicators, laboratory indicators, etc. ② Lack of necessary past and medication history. ③ History of drinking alcohol or excessive alcohol consumption: Over the past 12 months, the standard weekly alcohol consumption for males was 21 cups per week, while for females it was 14 cups per week. ④ Apply drugs such as amiodarone, methotrexate, tamoxifen, and glucocorticoids. ⑤ Specific diseases that can lead to fatty liver include genotype 3 hepatitis C virus infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, beta lipoproteinemia, congenital lipid atrophy, celiac disease, etc. ⑥ Patients with concomitant viral hepatitis, tumors, or other serious systemic diseases. ⑦ Individuals with limited or no capacity for civil conduct. ⑧ Pregnant patients.

研究实施时间：

Study execute time：

从 From 2024-09-01 00:00:00至 To 2028-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-01 00:00:00 至 To 2026-09-01 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

病理诊断为金标准。 非酒精性脂肪肝(NAFLD)：大泡性或大泡为主的脂肪变累及5%以上肝细胞，可以伴有轻度非特异性炎症。 非酒精性肝脂肪变(NAFL)：NAFLD的早期形式，定义为累及 ≥5% 的肝细胞的显着肝脂肪变性，但没有肝细胞损伤和肝纤维化的证据。 非酒精性脂肪性肝炎（NASH）：5%以上的肝细胞脂肪变合并小叶内炎症和肝细胞气球样变性。不合并肝纤维化或仅有轻度纤维化（F0~1）为早期NASH；合并显著肝纤维化或间隔纤维化（F2~3）为纤维化性NASH。 NAFLD相关肝硬化：合并肝硬化（F4）为NASH肝硬化。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

The pathological diagnosis is based on the gold standard. Non alcoholic fatty liver disease (NAFLD): Fatty changes characterized by large or predominantly large follicles involving more than 5% of liver cells may be accompanied by mild non-specific inflammation. Non alcoholic hepatic steatosis (NAFL): The early form of NAFLD, defined as significant hepatic steatosis involving ≥ 5% of liver cells, but without evidence of liver cell damage and fibrosis. Non alcoholic steatohepatitis (NASH): More than 5% of liver cell steatosis is accompanied by intralobular inflammation and hepatocyte ballooning degeneration. Early NASH is not accompanied by liver fibrosis or only mild fibrosis (F0-1); The combination of significant liver fibrosis or interstitial fibrosis (F2-3) is fibrotic NASH. NAFLD related cirrhosis: Concomitant cirrhosis (F4) is NASH cirrhosis.

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

BCAR3、METTL3、USP11、TRAF3表达情况

Index test:

Expression of BCAR3, USP11, METTL3, and TRAF3.

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

按照治疗医生的判断因非脂肪肝疾病需要行肝胆手术的患者，同时要求术后废弃肝组织标本有可供本实验需要的体积，大小至少2*2*2cm。

例数:

Sample size:

60

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

According to the judgment of the treating physician, patients who require liver and gallbladder surgery due to non fatty liver diseases are required to have a volume of at least 2 * 2 * 2cm of discarded liver tissue samples available for this experiment after surgery.

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

酒精性脂肪肝患者

例数:

Sample size:

60

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Patients with alcoholic fatty liver disease

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China

Province：

Guangdong Province

City：

Guangzhou City

单位(医院)：

 南方医科大学第五附属医院 

单位级别：

 三甲 

Institution
hospital：

The Fifth Affiliated Hospital of Southern Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

乳腺癌抗雌激素药物耐药性基因3

指标类型：

主要指标

Outcome：

Recombinant Breast Cancer Anti-Estrogen Resistance 3

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

甲基转移酶样蛋白3

指标类型：

主要指标

Outcome：

Methyltransferase-like protein 3

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

泛素特异性蛋白酶11

指标类型：

主要指标

Outcome：

ubiquitin specific peptidase 11

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肿瘤坏死因子受体相关因子蛋白3

指标类型：

主要指标

Outcome：

TNF receptor-associated factor 3

Type：

Primary 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：

肝细胞

组织：

肝

Sample Name：

Liver Cell

Tissue：

Liver

人体标本去向

 使用后保存  

说明

2028年8月1日研究结束，标本统一销毁

Fate of sample：

Preservation after use  

Note：

On August 1, 2028, the study was completed and the specimens were uniformly destroyed, the study was completed and the specimens were uniformly destroyed On July 1, 2028, the study was completed and the specimens were uniformly destroyed

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

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）：

不公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not publicly available

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：

采用Epidata进行数据管理，病历数据采用双人录入，录入负责人为主管医师和科室文员，录入后导出数据，数据不同部分重新录入。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Epidata is used for data management, and medical record data is entered by two people. The person in charge of entry is the supervising physician and department clerk. After entry, the data is exported and different parts of the data are re entered.

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：

  2024-08-30 11:40:09