今天是:2020-08-03 星期一

外泌体递送lncRNA UCA1增强糖酵解促宫颈癌淋巴管新生的作用及机制研究
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注册号:

Registration number:

ChiCTR2000034241 

最近更新日期:

Date of Last Refreshed on:

2020-06-30 

注册时间:

Date of Registration:

2020-06-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

外泌体递送lncRNA UCA1增强糖酵解促宫颈癌淋巴管新生的作用及机制研究 

Public title:

Cervical cancer-secreted exosomal lncRNA UCA1 promotes lymphangiogenesis by increasing glycolysis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

外泌体递送lncRNA UCA1增强糖酵解促宫颈癌淋巴管新生的作用及机制研究 

Scientific title:

Cervical cancer-secreted exosomal lncRNA UCA1 promotes lymphangiogenesis by increasing glycolysis 

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:

安兰芬 

研究负责人:

汪宏波 

Applicant:

An Lanfen 

Study leader:

Wang Hongbo 

申请注册联系人电话:

Applicant telephone:

+86 13035130849 

研究负责人电话:

Study leader's telephone:

+86 13720228749 

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:

alf9105@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hb_wang1969@sina.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:

中国湖北省武汉市解放大道1277号 

研究负责人通讯地址:

中国湖北省武汉市解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Wuhan, Hubei, China 

Study leader's address:

1277 Jiefang Avenue, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430022 

研究负责人邮政编码:

Study leader's postcode:

430022 

申请人所在单位:

华中科技大学同济医学院附属协和妇产科 

Applicant's institution:

Peking Union College of Gynecology and Obstetrics, Tongji Medical College, Huazhong University of Science and Technology 

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:

S1148 

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:

华中科技大学同济医学院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-16 

伦理委员会联系人:

陈汇 

Contact Name of the ethic committee:

Chen Hui 

伦理委员会联系地址:

武汉市航空路13号 

Contact Address of the ethic committee:

13 Hangkong Road, Wuhan, Huhan, China. 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 27-83691785 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

tongjilunli@163.com 

研究实施负责(组长)单位:

华中科技大学同济医学院附属协和医院妇产科 

Primary sponsor:

Peking Union College of Gynecology and Obstetrics, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

中国湖北省武汉市解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Wuhan, Hubei, China 

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):

Country:

China

Province:

Beijing

City:

单位(医院):

国家自然科学基金委员会

具体地址:

海淀区双清路83号

Institution
hospital:

National Natural Science Foundation of China

Address:

83 Shuangqing Road, Haidian District

经费或物资来源:

国家自然科学基金委员会 

Source(s) of funding:

National natural science foundation of China 

研究疾病:

宫颈癌 

Target disease:

Cervical cancer 

研究疾病代码:

H1621 

Target disease code:

H1621 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本课题拟从糖酵解的角度入手,通过临床标本、细胞和动物等多层面探究宫颈癌来源外泌体UCA1对淋巴管新生的调控作用,解析外泌体UCA1对LECs内miRNA及mRNA表达谱的影响,明确UCA1与c-Met竞争性结合miR-206在增强LECs糖酵解进而促淋巴管新生的作用机制。本项目旨在探讨外泌体UCA1/miR-206/c-Met信号途径在宫颈癌淋巴管新生中的作用,通过甄别该信号途径中的关键靶点为宫颈癌淋巴转移提供新的阻断策略。 

Objectives of Study:

From the perspective of glycolysis, this research aims to explore the regulatory effect of UCA1 on lymphangiogenesis by clinical specimens, cell and animal models, to analyze the of UCA1 on the expression profile of microRNAs and mRNAs in lymphoendothelial cells, and to clarify the role of competitive binding of UCA1 and c-Met to miR-206 in promoting the lymphangiogenesis by enhancing the glycolysis of lymphatic endothelial cells. The purpose of this project is to investigate the role of exosome UCA1/miR-206/c-Met signaling pathway in lymphangiogenesis of cervical cancer, and to provide a new strategy for blocking lymphatic metastasis of cervical cancer by identifying key targets in this signaling pathway. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

符合入选标准的子宫颈癌患者。 1. 所有宫颈组织取材前均无放、化疗及生物靶向治疗,全部病例取材后均经病理证实; 2. 研究人群无国籍、种族、年龄限制; 3.同意参加本试验并签署知情同意书,可定期随访者; 4. 患者能够提供血液及肿瘤组织标本; 5. 患者ECOG身体状态评分0或1; 6. 良好的器官功能。 

Inclusion criteria

Patients with cervical cancer met the inclusion criteria. 1. There were no radiotherapy, chemotherapy and biological targeted therapy before cervical tissue sampling, and all cases were confirmed by pathology; 2. The subjects are not restricted by nationality, race and age; 3. Patients who agree to participate in the trial and sign informed consent, and can be followed up regularly; 4. Patients can provide blood and tumor tissue samples; 5. ECoG score was 0 or 1; 6. Good organ function. 

排除标准:

1.有下列严重合并症者:心脏病、肝脏病、肾脏病、内分泌疾病等; 2. 患有传染病; 3.有尚未确诊的异常生殖道出血患者; 4. 合并其他肿瘤患者; 5.医生判断不适宜受试者; 6.有酗酒和吸毒史(试验前6个月内); 7. 受试者在受试前1月内使用过其他试验性药物。 

Exclusion criteria:

1. Patients with the following serious complications: heart disease, liver disease, kidney disease, endocrine disease, etc.; 2. Patients with infectious diseases; 2. Patients with undiagnosed abnormal genital tract bleeding; 3. Patients with other tumors; 4. Doctors judge the unsuitable subjects; 5. Patients with history of alcoholism and drug abuse (within 6 months before the trial); 6. The subjects used other experimental drugs within 1 month before the test. 

研究实施时间:

Study execute time:

From2020-07-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2020-07-01To 2023-12-31 

干预措施:

Interventions:

组别:

正常宫颈组织vs宫颈癌组织

样本量:

183

Group:

normal cervical tissue vs. cervical cancer tissue

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

宫颈组织

指标类型:

主要指标 

Outcome:

cervical tissue

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:

宫颈组织

组织:

Sample Name:

cervical tissue

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

https://pubmed.ncbi.nlm.nih.gov/

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

https://pubmed.ncbi.nlm.nih.gov/

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-06-29
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