ChiCTR2400082009 版本V1.0 版本创建时间2024/03/19 08:50:03 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：

ChiCTR2400082009 

最近更新日期：

Date of Last Refreshed on：

2024-03-19 08:49:58 

注册时间：

Date of Registration：

2024-03-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

微小核糖核酸（miR-21，miR-125a，miR-150）和甲胎蛋白联合检测试剂盒（PCR荧光探针法-磁微粒化学发光免疫分析法）&微小核糖核酸（miR-21，miR-125a，miR-150）和甲胎蛋白联合分析软件临床试验

Public title：

A clinical trial of Micro-RNAs (miR-21, miR-125a, miR-150) and alpha fetoprotein combined detection kit (PCR fluorescent probe method-magnetic particle chemiluminescence immunoassay) & Micro-RNAs (miR-21, miR-125a, miR-150 ) and alpha fetoprotein combined analysis software

注册题目简写：

肝癌外泌体试剂盒&分析软件临床试验

English Acronym：

A clinical trial of exosomes of liver cancer detection kit and analysis software

研究课题的正式科学名称：

微小核糖核酸（miR-21，miR-125a，miR-150）和甲胎蛋白联合检测试剂盒（PCR荧光探针法-磁微粒化学发光免疫分析法）&微小核糖核酸（miR-21，miR-125a，miR-150）和甲胎蛋白联合分析软件临床试验

Scientific title：

A clinical trial of Micro-RNAs (miR-21, miR-125a, miR-150) and alpha fetoprotein combined detection kit (PCR fluorescent probe method-magnetic particle chemiluminescence immunoassay) & Micro-RNAs (miR-21, miR-125a, miR-150) and alpha fetoprotein combined analysis software

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：

丁晓瑜 

研究负责人：

王琦/陈京龙/王雅杰 

Applicant：

Xiao Yu Ding 

Study leader：

Wang Qi/Chen Jing Long/Wang Ya Jie 

申请注册联系人电话：

Applicant telephone：

+86 151 0105 8381

研究负责人电话：

Study leader's telephone：

+86 156 1126 5361

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：

xiaoyu.ding@hotgen.com.cn

研究负责人电子邮件：

Study leader's E-mail：

wangqidl04@126.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：

北京市大兴生物医药产业基地庆丰西路 55 号院

研究负责人通讯地址：

北京市朝阳区京顺东街8号

Applicant address：

55 Qingfeng West Road, Daxing Biomedical Industry Base, Beijing

Study leader's address：

8 Jingshun East Street, Chaoyang District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

102629

研究负责人邮政编码：

Study leader's postcode：

100015

申请人所在单位：

北京热景生物技术股份有限公司

Applicant's institution：

Beijing Hotgen Biotechnology Co., Ltd

研究负责人所在单位：

首都医科大学附属北京地坛医院

Affiliation of the Leader：

Beijing Ditan Hospital, Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

京地伦试剂字[2024]第(002)-01号

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：

首都医科大学附属北京地坛医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Ditan Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-01 00:00:00

伦理委员会联系人：

张如意

Contact Name of the ethic committee：

Zhang Ruyi

伦理委员会联系地址：

北京市朝阳区京顺东街8号

Contact Address of the ethic committee：

8 Jingshun East Street, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8432 2127

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：

首都医科大学附属北京地坛医院

Primary sponsor：

Beijing Ditan Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市朝阳区京顺东街8号

Primary sponsor's address：

8 Jingshun East Street, Chaoyang District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

大兴区

Country：

China

Province：

Beijing

City：

Daxing District

单位(医院)：

北京热景生物技术股份有限公司

具体地址：

北京市大兴生物医药产业基地庆丰西路 55 号院

Institution
hospital：

Beijing Hotgen Biotechnology Co., Ltd

Address：

55 Qingfeng West Road, Daxing Biomedical Industry Base, Beijing

经费或物资来源：

北京热景生物技术股份有限公司

Source(s) of funding：

Beijing Hotgen Biotechnology Co., Ltd

Target disease：

Hepatocellular,HCC

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 诊断试验新技术临床试验 

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

本临床试验目的为： （1）以影像学诊断和/或病理诊断结果作为临床参考标准，本试剂盒检测及软件分析的结果与临床参考标准进行同步比较，验证评价试剂和试验软件用于肝细胞癌辅助诊断的有效性。 （2）验证评价试剂对人血清样本细胞外囊泡中的3种微小核糖核酸（miR-21，miR-125a，miR-150）和血清样本中AFP的检测准确性。 （3）验证评价试剂对肝细胞癌肝切除术或消融治疗术前后诊断的有效性。 （4）通过识别软件的缺陷及数据分析过程中产生的不良/严重不良事件的发生情况，验证试验软件的安全性。  

Objectives of Study：

The objectives of this clinical trial: (1) Using imaging diagnosis and/or pathological diagnosis results as clinical reference standards, the results of this kit and software analysis are compared synchronously with clinical reference standards to verify the effectiveness of evaluation reagents and test software in the auxiliary diagnosis of hepatocellular carcinoma. (2) Verify the accuracy of the evaluation reagent in detecting three types of Micro-RNAs (miR-21, miR-125a, miR-150) in extracellular vesicles of human serum samples and AFP in serum samples. (3) Verify the effectiveness of evaluation reagents in the diagnosis of hepatocellular carcinoma before and after hepatectomy or ablation therapy. (4) Verify the safety of the test software by identifying software defects and identifying the occurrence of adverse/serious adverse events during the data analysis process.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

满足以下所有条件的样本，可以作为临床试验用样本入选： （1）受试者应符合以下任一条件： ①肝脏有占位性病变，且性质不明人群（肝内结节直径＞2cm：多参数 MRI、动态增强 CT、超声造影或肝细胞特异性对比剂 Gd-EOB-DTPA 增强 MRI，4种影像学检查中均未呈现典型的肝癌特征；肝内结节直径≤2cm：4种影像学检查中最多有1项显示典型的肝癌特征）人群。 ②肝脏有占位性病变，初次诊断确诊为原发性肝细胞癌（HCC）的人群。该部分受试者应包括不同的分期（CNLC Ⅰ期、Ⅱ期、Ⅲ期、Ⅳ期）。 其中应包括，行肝切除术或消融治疗术且需手术后2 ~3个月回院复查的HCC患者。 ③肝脏有占位性病变，诊断为肝转移瘤的人群。 ④诊断为其他消化系统肿瘤或非消化系统肿瘤的受试者，包括：肝内胆管癌（ICC）、混合型肝细胞癌-胆管癌（cHCC-CCA）、胃癌、结直肠癌、食道癌、肺癌、乳腺癌等。 ⑤诊断为肝脏良性疾病的受试者，包括肝囊肿、肝血管瘤、腺瘤、病毒性肝炎、脂肪肝、肝硬化人群。 （2）提供样本的受试者应有明确的病例信息，包括门诊号/住院号、样本编号、年龄、性别、临床诊断等。受试者的年龄不小于18周岁，性别不限。 （3）自愿参与本临床试验，能够被采集外周血样本的受试者。

Inclusion criteria

Samples that meet all the following conditions can be selected as clinical trial samples: (1) The subjects shall meet any of the following conditions: ① Population with liver’s space-occupying lesions and unknown nature(Intrahepatic nodule diameter > 2cm: MRI enhanced by multi-parameter MRI, dynamic enhanced CT, contrast-enhanced ultrasound or hepatocellular specific contrast agent Gd-EOB-DTPA showed no typical characteristics of liver cancer in the four imaging examinations. Intrahepatic nodules ≤2cm in diameter: up to 1 of the 4 imaging studies showed typical liver cancer features). ② Population with liver’s space-occupying lesions and initial diagnosis of primary hepatocellular carcinoma (HCC). This group of subjects should include different stages (CNLC stages I, II, III, IV). This should include HCC patients who have undergone hepatectomy or ablation therapy and need to return to the hospital for reexamination 2-3 months after surgery. ③ Population with liver’s space-occupying lesions and diagnosis of liver metastases. ④ Subjects diagnosed as other digestive system tumors or non-digestive system tumors, including: intrahepatic cholangiocarcinoma (ICC), Mixed hepatocellular carcinoma - Cholangiocarcinoma (cHCC-CCA), gastric cancer, colorectal cancer, esophageal cancer, lung cancer, breast cancer, etc. ⑤Subjects diagnosed with benign liver diseases included hepatic cysts, liver hemangiomas, adenoid tumor, viral hepatitis, fatty liver, and cirrhosis. (2) The subjects providing the sample should have clear case information, including outpatient/inpatient number, sample number, age, gender, clinical diagnosis, etc. The age of the subjects is not less than 18 years old and the gender is not limited. (3) Subjects who voluntarily participate in this clinical trial and are able to collect peripheral blood samples.

排除标准：

具有以下一条或多条的受试者样本，应予以排除： （1）6个月内接受过免疫或靶向药物治疗的肝癌患者。 （2）受试者病例信息不完整，不满足入选标准第（2）的样本。 （3）样本采集、保存不符合评价试剂和对比试剂/方法要求的样本。

Exclusion criteria：

Subject samples with one or more of the following shall be excluded: (1) Patients with liver cancer who have received immunotherapy or targeted drug therapy within 6 months. (2) The medical information of the subjects was incomplete, and the samples did not meet the inclusion criteria (2). (3) Samples collected and stored that do not meet the requirements of evaluation reagents and comparative reagents/methods.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-01 00:00:00 至 To 2024-12-31 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）：

肝细胞癌的临床诊断（包括但不限于影像学、病理学、血清学等诊断结果）

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):

Clinical diagnosis of hepatocellular carcinoma (including but not limited to imaging, pathology, serology, etc.)

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）：

1、产品用于人血清样本细胞外囊泡中的3种微小核糖核酸（miR-21，miR-125a，miR-150）检测性能评价； 2、产品用于血清样本中AFP检测性能评价； 3、产品在肝细胞癌肝切除术或消融治疗术手术前后检测结果变化情况的评价； 4、针对配套分析软件进行可用性和安全性评价。

Index test:

1. The product is used to evaluate the detection performance of three micrornas (miR-21, miR-125a, miR-150) in extracellular vesicles of human serum samples; 2. The product is used to evaluate the AFP detection performance in serum samples; 3. Evaluation of changes in test results before and after hepatectomy or ablation for hepatocellular carcinoma; 4. Conduct usability and security evaluation for supporting analysis software.

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）

目标人群为原发性肝细胞癌的疑似人群，即临床肝脏影像学检查和既有临床检查怀疑肝脏占位性病变的患者。

例数:

Sample size:

100

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):

The target population is suspected population of primary hepatocellular carcinoma, that is, patients suspected of hepatic space occupying lesion by clinical imaging examination and existing clinical examination.

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）：

1、肝脏有占位性病变，初次诊断确诊为原发性肝细胞癌（HCC）的人群； 2、肝脏有占位性病变，诊断为肝转移瘤的人群； 3、诊断为其他消化系统肿瘤或非消化系统肿瘤的患者，包括：肝内胆管癌（ICC）、混合型肝细胞癌-胆管癌（cHCC-CCA）、胃癌、结直肠癌、食道癌、肺癌、乳腺癌等； 4、诊断为肝脏良性疾病的人群，包括肝囊肿、肝血管瘤、腺瘤、病毒性肝炎、脂肪肝，肝硬化人群。

例数:

Sample size:

800

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

1. People with space-occupying lesions in the liver who are initially diagnosed with primary hepatocellular carcinoma (HCC); 2. People with space-occupying lesions in the liver and diagnosed as liver metastases; 3. Patients diagnosed with other digestive system tumors or non-digestive system tumors, including: intrahepatic cholangiocarcinoma (ICC), mixed hepatocellular carcinoma-cholangiocarcinoma (cHCC-CCA), gastric cancer, colorectal cancer, esophageal cancer, lung cancer, breast cancer, etc. 4. People diagnosed with benign liver diseases, including liver cysts, liver hemangiomas, adenomas, viral hepatitis, fatty liver, and cirrhosis.

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 朝阳区 

Country：

China 

Province：

Beijing 

City：

Chaoyang District 

单位(医院)：

首都医科大学附属北京地坛医院 

单位级别：

三甲 

Institution
hospital：

Beijing Ditan Hospital Affiliated to Capital Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 朝阳区 

Country：

China 

Province：

Beijing 

City：

Fengtai District 

单位(医院)：

首都医科大学附属北京佑安医院 

单位级别：

三甲 

Institution
hospital：

Beijing You'an Affiliated to Capital Medical University hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

 石家庄 

Country：

China 

Province：

Hebei 

City：

Shijiazhuang 

单位(医院)：

石家庄市第五医院 

单位级别：

三甲 

Institution
hospital：

Shijiazhuang fifth hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

 西安 

Country：

China 

Province：

Shaanxi 

City：

Xi 'an 

单位(医院)：

西安交通大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Xi 'an Jiaotong University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

微小核糖核酸miR-21

指标类型：

主要指标

Outcome：

Micro-RNA miR-21

Type：

Primary indicator

测量时间点：

血清分离应在静脉采血后 6 小时内完成。经上述处理后的血清样本需立即用于检测，或于-25℃~ -15℃保存不超过 3 个月且冻融不超过 1 次，或于 -85℃~ -75℃保存不超过 12 个月且冻融不超过 1 次。

测量方法：

PCR 荧光探针法-磁微粒化学发光免疫分析法

Measure time point of outcome：

Serum centrifugation should be completed within 6 hours after venous blood collection. The serum samples processed above should be immediately used for testing, or stored at -25 ℃~-15 ℃ for no more than 3 months with no more than 1 freeze-thaw cycle, or stored at -85 ℃~-75 ℃ for no more than 12 months with no more than 1 freeze-thaw cycle.

Measure method：

PCR fluorescent probe method-magnetic particle chemiluminescence immunoassay

指标中文名：

微小核糖核酸miR-125a

指标类型：

主要指标

Outcome：

Micro-RNA miR-125a

Type：

Primary indicator

测量时间点：

血清分离应在静脉采血后 6 小时内完成。经上述处理后的血清样本需立即用于检测，或于-25℃~ -15℃保存不超过 3 个月且冻融不超过 1 次，或于 -85℃~ -75℃保存不超过 12 个月且冻融不超过 1 次。

测量方法：

PCR 荧光探针法-磁微粒化学发光免疫分析法

Measure time point of outcome：

Serum centrifugation should be completed within 6 hours after venous blood collection. The serum samples processed above should be immediately used for testing, or stored at -25 ℃~-15 ℃ for no more than 3 months with no more than 1 freeze-thaw cycle, or stored at -85 ℃~-75 ℃ for no more than 12 months with no more than 1 freeze-thaw cycle.

Measure method：

PCR fluorescent probe method-magnetic particle chemiluminescence immunoassay

指标中文名：

微小核糖核酸miR-150

指标类型：

主要指标

Outcome：

Micro-RNA miR-150

Type：

Primary indicator

测量时间点：

血清分离应在静脉采血后 6 小时内完成。经上述处理后的血清样本需立即用于检测，或于-25℃~ -15℃保存不超过 3 个月且冻融不超过 1 次，或于 -85℃~ -75℃保存不超过 12 个月且冻融不超过 1 次。

测量方法：

PCR 荧光探针法-磁微粒化学发光免疫分析法

Measure time point of outcome：

Serum centrifugation should be completed within 6 hours after venous blood collection. The serum samples processed above should be immediately used for testing, or stored at -25 ℃~-15 ℃ for no more than 3 months with no more than 1 freeze-thaw cycle, or stored at -85 ℃~-75 ℃ for no more than 12 months with no more than 1 freeze-thaw cycle.

Measure method：

PCR fluorescent probe method-magnetic particle chemiluminescence immunoassay

指标中文名：

甲胎蛋白

指标类型：

主要指标

Outcome：

AFP(alpha fetoprotein)

Type：

Primary indicator

测量时间点：

静脉采血后 24 小时内分离血清。血清样本在 2℃～8℃储存 时间不超过 1 周。如果无法在采血后 1 周内进行测定，则将样本密封后，于-25℃~ -15℃保存不超过 1 个月，反复冻融次数不超过 3 次

测量方法：

PCR 荧光探针法-磁微粒化学发光免疫分析法

Measure time point of outcome：

Centrifuge within 24 hours after venous blood collection to obtain serum samples. Serum samples should be stored at 2 ℃ to 8 ℃ for no more than one week. If the measurement cannot be conducted within one week after blood collection, the sample should be sealed and stored at -25 ℃~-15 ℃ for no more than one month, with no more than three repeated freeze-thaw cycles.

Measure method：

PCR fluorescent probe method-magnetic particle chemiluminescence immunoassay

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血清

组织：

静脉全血

Sample Name：

serum

Tissue：

venous whole blood

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destruction after use

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 80 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）：

应对所有完成入选的样本进行统一编盲，用随机数生成器产生随机序列。

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

All the selected samples should be uniformly compiled, and random number generator should be used to generate random sequences.

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：

本临床试验，应对所有完成入选的样本进行统一编盲，临床试验检测在盲法前提下进行。负责编盲的研究者/样本收集研究者与负责检测的研究者不能为同一个人。试验过程中，负责样本检测和软件可用性和安全性评价的研究者仅可看到编盲号。

Blinding：

In this clinical trial, all the selected samples should be uniformly coded blind, and the clinical test should be carried out under the premise of blind method. The investigator/sample collection investigator in charge of blinding and the investigator in charge of testing cannot be the same person. During the trial, researchers responsible for sample testing and software usability and safety evaluation can only see the blind number.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

临床试验结题后，原始数据库及所有记录文件均应按照规定存档，任何人不得随意翻阅、篡改。如国家药品监督管理局、中国人民共和国国家卫生健康委员会等机构进行核查、检查时，研究组成员应在保护受试者隐私相关的信息不被泄露的情况下，同意核查、检查人员直接访问源数据及文件。

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

After the clinical trial is completed, the original database and all record files shall be archived according to regulations, and no one is allowed to browse or tamper with them at will. When institutions such as the National Medical Products Administration and the National Health Commission of the People's Republic of China conduct verification and inspection, members of the research team should agree to allow verification and inspection personnel to directly access source data and documents while protecting the privacy related information of the subjects from being leaked.

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：

8.1 数据管理基本要求 （1）临床试验数据应具有可追溯性，临床试验报告、病例报告表（如有）、临床试验数据表以及临床试验中的检验报告（如有）等文件中的数据均应一致且可以追溯至原始检验记录。 （2）对显著偏离临床试验方案或者在临床可接受范围以外的数据应当加以核实，由研究者作必要的说明。 8.2 临床试验数据保密要求 本临床试验对受试者的所有相关资料和数据均应进行保密管理。本次临床试验所涉及的所有与受试者隐私相关的信息，都应严格保密。除国家药品监督管理局、中华人民共和国卫生健康委员会等机构进行核查、检查要求提供之外，研究组成员应保证在任何其他情况下，不能将与受试者隐私相关的信息泄露给包括申办方在内的任何机构、人员。 8.3 临床试验数据递交要求 临床试验完成后，研究者应对临床试验数据进行规范地收集、整理和分析。注册申请人依据《体外诊断试剂临床试验数据递交要求注册审查指导原则》和《医疗器械临床试验数据递交要求注册审查指导原则》具体要求完成临床试验数据递交。 8.4 原始资料保存 在临床试验过程中产生的原始数据应录入病例报告表，临床试验研究者对临床试验数据进行整理，临床试验统计学负责人对临床试验数据进行统计分析。分析后得出结论，主要研究者应基于临床试验结论完成临床试验报告。 此次临床验证全部原始数据，保存于承担临床试验的4家医疗机构。

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

8.1 Basic Requirements for Data Management (1) Clinical trial data should be traceable, and the data in clinical trial reports, case report forms (if any), clinical trial data sheets, clinical trial test reports (if any) and other documents should be consistent and traceable to the original test records. (2) Significant deviations from the clinical trial protocol or data outside the acceptable clinical range should be verified, and necessary explanations should be provided by the researcher. 8.2 Confidentiality requirements for clinical trial data All relevant information and data of the subjects in this clinical trial shall be kept confidential. All information related to the privacy of the subjects involved in this clinical trial shall be kept strictly confidential. Except for verification and inspection by institutions such as the National Medical Products Administration and the Health Commission of the People's Republic of China, research team members shall ensure that under no other circumstances, information related to the privacy of subjects shall be disclosed to any institution or personnel, including the sponsor. 8.3 Requirements for clinical trial data submission After the completion of clinical trials, researchers should collect, organize and analyze clinical trial data in a standardized manner. The registration applicant shall complete the clinical trial data submission in accordance with the specific requirements of the "Guidelines for Registration Review of in vitro Diagnostic Reagent Clinical Trial Data Submission Requirements" and the "Guidelines for Registration Review of Medical Device Clinical Trial Data Submission Requirements". 8.4 Save the original data The original data generated in the process of clinical trial should be recorded in the case report form. The clinical trial researcher will sort out the clinical trial data, and the head of clinical trial statistics will conduct statistical analysis of the clinical trial data. After the analysis, it is concluded that the principal investigator should complete the clinical trial report based on the clinical trial conclusions. All the original data of this clinical validation are stored in the four medical institutions that undertook the clinical trial.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-03-19 08:49:58