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Study for endometrial cancer progression using transcriptome profiling and AMP-activated protein kinase modulation
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注册号:

Registration number:

ChiCTR1900028560 

最近更新日期:

Date of Last Refreshed on:

2019-12-28 

注册时间:

Date of Registration:

2019-12-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

使用转录组分析和AMP激活蛋白激酶调节研究子宫内膜癌进展 

Public title:

Study for endometrial cancer progression using transcriptome profiling and AMP-activated protein kinase modulation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

使用转录组分析和AMP激活蛋白激酶调节研究子宫内膜癌进展 

Scientific title:

Study for endometrial cancer progression using transcriptome profiling and AMP-activated protein kinase modulation 

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:

李贤 

研究负责人:

陈卫 

Applicant:

Li Xian 

Study leader:

David Chan 

申请注册联系人电话:

Applicant telephone:

+86 13688815534 

研究负责人电话:

Study leader's telephone:

+852 98026120 

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:

lix1@hku-szh.org 

研究负责人电子邮件:

Study leader's E-mail:

dwchan@hku.hk 

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:

广东省深圳市福田区海园一路香港大学深圳医院妇产科 

研究负责人通讯地址:

广东省深圳市福田区海园一路香港大学深圳医院妇产科 

Applicant address:

The University of Hong Kong, Shenzhen Hospital, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

Gynaecology and obstetrics department of The University of Hong Kong, Shenzhen Hospital, Futian District, Shenzhen, Guangdong, China 

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:

香港大学深圳医院 

Applicant's institution:

Gynaecology and Obstetrics Department of Shenzhen Hospital, The University of Hong Kong 

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:

伦[2019]179 

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:

香港大学深圳医院医学研究伦理委员会 

Name of the ethic committee:

Medical research ethics committee of the University of Hong Kong shenzhen hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-16 

伦理委员会联系人:

王静贤 

Contact Name of the ethic committee:

Wang Jingxian 

伦理委员会联系地址:

广东省深圳市福田区海园一路香港大学深圳医院后勤服务楼616 

Contact Address of the ethic committee:

The University of Hong Kong shenzhen hospital,Logistics service building Room616 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0755 86913175 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

mec@hku-szh.org 

研究实施负责(组长)单位:

香港大学深圳医院 

Primary sponsor:

The University of Hong Kong shenzhen hospital 

研究实施负责(组长)单位地址:

深圳市福田区海园一路香港大学深圳医院 

Primary sponsor's address:

The University of Hong Kong shenzhen hospital,Haiyuan 1st road, Futian district, shenzhen 

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):

深圳市

Country:

China

Province:

Guangdong

City:

单位(医院):

香港大学深圳医院

具体地址:

深圳市福田区海园一路香港大学深圳医院

Institution
hospital:

The University of Hong Kong shenzhen hospital

Address:

The University of Hong Kong, Shenzhen Hospital, Futian District, Shenzhen

经费或物资来源:

香港大学深圳医院 

Source(s) of funding:

The University of Hong Kong shenzhen hospital 

研究疾病:

子宫内膜癌 

Target disease:

Endometrial cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

子宫内膜癌是生殖系统最常见的女性癌症之一,中国女性的发病率和死亡率都在快速增长,给我们的社会带来了巨大的经济负担。虽然这种疾病的确切病因至今仍无定论,但新出现的证据表明,代谢紊乱如肥胖和糖尿病与子宫内膜癌的发展密切相关。因此,迫切需要更好地了解癌症易感性的遗传/表观遗传改变和种族背景,以探索更好的治疗方案。在该提案中,我们将通过RNA-Seq和下一代测序(NGS)研究子宫内膜癌1-4期的转录体表观遗传现象。由于亚洲人、白人和/或黑人之间大多数妇科癌症的发病率和死亡率不同,研究种族背景在子宫内膜癌发展中的相关性至关重要。此外,在一个群体中鉴定的评估癌症易感性中遗传变异的临床应用越来越重要。因此,我们将利用我们的RNA-Seq数据与癌症基因组图谱(TCGA)数据库相结合进行生物信息学分析。最后,AMP激活蛋白激酶(AMPK)是维持能量稳态的中枢调节因子,它还在癌症进展中发挥促或抗肿瘤作用。由于AMPK亚基还具有致癌作用,评估它们的表达是非常重要的。我们认为这项提案是深入调查破译中国女性子宫内膜癌病因和发病机制的启动研究。 

Objectives of Study:

Endometrial cancer is one of the most common female cancer of genital system. The rapid growth of both incidence and mortality rates in Chinese women, causing enormous economic burden to our society. Although the etiology of this disease remains elusive, emerging evidence indicates metabolic disorders such as obesity and diabetes are closely associated with the development of endometrial cancer. Therefore, its an urgent need to better understand the genetic/epigenetic alterations and ethnic background in cancer susceptibility for exploring better treatment regimens. In this proposal, we will study the transciptome landscape at tumor stages 1-4 of endometrial cancer by RNA-Seq with next-generation sequencing (NGS). Besides, the clinical use of genetic variation in the evaluation cancer susceptibility identified in one population is of growing importance. Due to the difference in incidence and mortality rates of most gynaecological cancers between Asian, white European and/or Black peoples, its of crucial to study the relevance of ethnic background in the development of endometrial cancer. Hence, we will utilize our RNA-Seq data combined with the database of The Cancer Genome Atlas (TCGA) for bioinformatics analysis. Finally, AMP-activated protein kinase (AMPK) is a central regulator for maintaining energy homeostasis, and it also exerts pro- or anti-tumorigenic roles in cancer progression. It’s of important to evaluate the expression of AMPK subunits due to their roles in carcinogenesis. We believe this proposal is the kick-off study for initiation of the deeper investigations of deciphering the etiology and pathogenesis of endometrial cancer in Chinese women. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

组织学证实的子宫内膜癌患者; 年龄大于18岁小于85岁,可以理解并签署知情同意。 

Inclusion criteria

Patients Histologically confirmed endometrial cancer; Age greater than 18 and less than 85, who can understood and signed informed consent. 

排除标准:

合并有其他肿瘤的病人; 在医学上不适合手术的病人。 

Exclusion criteria:

Patients with other tumors; Medically unfit for surgery. 

研究实施时间:

Study execute time:

From2019-12-27To 2022-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

60

Group:

Case series

Sample size:

干预措施:

Nil

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):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

香港大学深圳医院 

单位级别:

三级甲等 

Institution
hospital:

The University of Hong Kong shenzhen hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

AMP激活蛋白激酶

指标类型:

主要指标 

Outcome:

AMPK

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:

手术病理组织

组织:

Sample Name:

Surgical pathological 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 18 years
最大 Max age 85 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):

No

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

No

盲法:

No

Blinding:

No

原始数据公开时间:

The time of sharing IPD:

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):

2022年12月31日 https://www.hku-szh.org/ ; https://www.hku-szh.org/

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

December 31, 2022 https://www.hku-szh.org/ ; https://www.hku-szh.org/

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:

病例记录表 + Excel 登记表

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

Case Record Form + Excel Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-27
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