亚洲人群衰老图谱与年龄相关胰腺癌等疾病易感性

注册号:

Registration number:

ChiCTR2600127076 

最近更新日期:

Date of Last Refreshed on:

2026-06-24 10:54:54 

注册时间:

Date of Registration:

2026-06-24 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

亚洲人群衰老图谱与年龄相关胰腺癌等疾病易感性

Public title:

Asian population aging Atlas and age related pancreatic cancer and other disease susceptibility

注册题目简写:

English Acronym:

研究课题的正式科学名称:

亚洲人群衰老图谱与年龄相关胰腺癌等疾病易感性

Scientific title:

Asian population aging Atlas and age related pancreatic cancer and other disease susceptibility

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:

符达 

研究负责人:

符达 

Applicant:

Da Fu 

Study leader:

Da Fu 

申请注册联系人电话:

Applicant telephone:

+86 15921527578

研究负责人电话:

Study leader's
telephone:

+86 21 34186000

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:

fd12374@rjh.com.cn

研究负责人电子邮件:

Study leader's E-mail:

fuda@shsmu.edu.cn

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:

上海市黄浦区瑞金二路197号

研究负责人通讯地址:

上海市瑞金二路197号

Applicant address:

197 Ruijin Er Road, Huangpu District, Shanghai

Study leader's address:

197 Rui Jin 2nd Road, Shanghai, 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:

上海交通大学医学院附属瑞金医院

Applicant's institution:

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位:

上海交通大学医学院附属瑞金医院

Affiliation of the Leader:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2026临伦审第94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:

上海交通大学医学院附属瑞金医院涉及人体的临床与科研项目伦理委员会

Name of the ethic committee:

Ruijin Hospital Ethics Committee, Shanghai JiaoTong University School of Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-28 00:00:00

伦理委员会联系人:

赵彦琳

Contact Name of the ethic committee:

Zhao YanLin

伦理委员会联系地址:

上海市瑞金二路197号

Contact Address of the ethic committee:

197 Rui Jin 2nd Road, Shanghai, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 80585870

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zyl02d86@rjh.com.cn

研究实施负责(组长)单位:

上海交通大学医学院附属瑞金医院

Primary sponsor:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

研究实施负责(组长)单位地址:

上海市瑞金二路197号

Primary sponsor's address:

197 Rui Jin 2nd Road, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市瑞金二路197号

Institution
hospital:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Address:

197 Rui Jin 2nd Road, Shanghai, China

经费或物资来源:

“政府间国际科技创新合作”重点专项

Source(s) of funding:

National Key Research and Development Program of China

研究疾病:

胰腺癌  

Target disease:

Pancreatic cancer

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:

主要目的:通过利用亚洲人群的多组学数据,破解生物衰老时钟,预测癌症风险和结果。 具体目标:利用新加坡 Xiaotao Shen 教授开发的最先进的代谢组学和脂质组学方法,开发和验证胰腺特异性衰老时钟,确保对亚洲人口中种族多样性数据集的访问和生物衰老时钟的交叉验证。 分级目标:(1)描述亚洲人群的非线性衰老动力学 ;(2)开发和验证胰腺特异性衰老时钟 ;(3)对照良性表型组织样本验证时钟以将胰腺老化与癌症风险。  

Objectives of Study:

The primary objective is to elucidate the biological aging mechanism and predict cancer risk and clinical outcomes by integrating multi-omics data derived from the Asian population. Specific aims include leveraging state-of-the-art metabolomics and lipidomics methodologies developed by Professor Xiaotao Shen of Singapore to construct and validate a pancreas-specific aging clock, ensuring access to a diverse and representative dataset from the Asian population and enabling cross-validation of the biological aging model. Tiered objectives are as follows: (1) characterize nonlinear patterns in aging dynamics within the Asian population; (2) develop and validate a pancreas-specific epigenetic aging clock; and (3) evaluate the clock’s performance using benign pancreatic tissue samples to establish correlations between pancreatic aging and cancer susceptibility.

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

排除标准:

1.无;

Exclusion criteria:

1.None;

研究实施时间:

Study execute time:

From 2026-07-01 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-07-01 00:00:00 To 2028-12-31 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

300

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

病例组

样本量:

300

Group:

Case group

Sample size:

干预措施:

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):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

基因组学

指标类型:

主要指标

Outcome:

Genomics

Type:

Primary indicator

测量时间点:

以从瑞金医院样本库收样时间为准

测量方法:

研究涉及的血清标本将交由上海美吉生物医药科技有限公司进行基因组学检测。血清样本于-80℃保存,4℃条件进行检测,1-2个月内检测完毕。

Measure time point of outcome:

Based on the sample collection time from the Ruijin Hospital sample bank

Measure method:

The serum samples involved in the research will be sent to Shanghai Meiji Biomedical Technology Co., Ltd. for genomic analyses. The serum samples will be stored at -80℃ and tested under 4℃ conditions. The tests will be completed within 1-2 months.

指标中文名:

蛋白质组学

指标类型:

主要指标

Outcome:

Proteomics

Type:

Primary indicator

测量时间点:

以从瑞金医院样本库收样时间为准

测量方法:

研究涉及的血清标本将交由上海美吉生物医药科技有限公司进行蛋白质组学检测。血清样本于-80℃保存,4℃条件进行检测,1-2个月内检测完毕。

Measure time point of outcome:

Based on the sample collection time from the Ruijin Hospital sample bank

Measure method:

The serum samples involved in the research will be sent to Shanghai Meiji Biomedical Technology Co., Ltd. for proteomic analyses. The serum samples will be stored at -80℃ and tested under 4℃ conditions. The tests will be completed within 1-2 months.

指标中文名:

代谢组学

指标类型:

主要指标

Outcome:

Metabolomics

Type:

Primary indicator

测量时间点:

以从瑞金医院样本库收样时间为准

测量方法:

研究涉及的血清标本将交由上海美吉生物医药科技有限公司进行代谢组学检测。血清样本于-80℃保存,4℃条件进行检测,1-2个月内检测完毕。

Measure time point of outcome:

Based on the sample collection time from the Ruijin Hospital sample bank

Measure method:

The serum samples involved in the research will be sent to Shanghai Meiji Biomedical Technology Co., Ltd. for metabolomic analyses. The serum samples will be stored at -80℃ and tested under 4℃ conditions. The tests will be completed within 1-2 months.

指标中文名:

转录组学

指标类型:

主要指标

Outcome:

Transcriptomics

Type:

Primary indicator

测量时间点:

以从瑞金医院样本库收样时间为准

测量方法:

研究涉及的血清标本将交由上海美吉生物医药科技有限公司进行转录组学检测。血清样本于-80℃保存,4℃条件进行检测,1-2个月内检测完毕。

Measure time point of outcome:

Based on the sample collection time from the Ruijin Hospital sample bank

Measure method:

The serum samples involved in the research will be sent to Shanghai Meiji Biomedical Technology Co., Ltd. for transcriptomic analyses. The serum samples will be stored at -80℃ and tested under 4℃ conditions. The tests will be completed within 1-2 months.

指标中文名:

脂质组学

指标类型:

主要指标

Outcome:

Lipomics

Type:

Primary indicator

测量时间点:

以从瑞金医院样本库收样时间为准

测量方法:

研究涉及的血清标本将交由上海美吉生物医药科技有限公司进行脂质组学检测。血清样本于-80℃保存,4℃条件进行检测,1-2个月内检测完毕。

Measure time point of outcome:

Based on the sample collection time from the Ruijin Hospital sample bank

Measure method:

The serum samples involved in the research will be sent to Shanghai Meiji Biomedical Technology Co., Ltd. for lipidomic analyses. The serum samples will be stored at -80℃ and tested under 4℃ conditions. The tests will be completed within 1-2 months.

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血清样本

组织:

Sample Name:

Serum sample

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

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:

None

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号之后会将数据共享至“美吉生信云”网站(www.majorbio.com)。

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

After December 31, 2028, the data will be shared to the "MajorBio Cloud" website (www.majorbio.com).

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:

研究对象资料(包括相关表格、记录、样本及研究对象隐私)均由该项目负责人保管,该项目参与人员可获取资料,并且在没有获批同意之前任何研究信息不能向未授权的第三方透露。

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

The research subject data (including relevant forms, records, samples and the privacy of the research subjects) are all kept by the project leader. Project participants can access the data, but any research information must not be disclosed to unauthorized third parties without the approval and consent.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-06-24 10:54:31