胰腺癌恶病质空间多组学机制解析与多模态智能预警研究

注册号:

Registration number:

ChiCTR2600122587 

最近更新日期:

Date of Last Refreshed on:

2026-04-15 16:16:41 

注册时间:

Date of Registration:

2026-04-15 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

胰腺癌恶病质空间多组学机制解析与多模态智能预警研究

Public title:

Spatial multi-omics mechanism analysis and multimodal intelligent early warning of cachexia in pancreatic cancer

注册题目简写:

English Acronym:

研究课题的正式科学名称:

胰腺癌恶病质空间多组学机制解析与多模态智能预警研究

Scientific title:

Spatial multi-omics mechanism analysis and multimodal intelligent early warning of cachexia in pancreatic cancer

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:

张靖承 

研究负责人:

吴文铭 

Applicant:

Jincheng Zhang 

Study leader:

Wenming Wu 

申请注册联系人电话:

Applicant telephone:

+86 10 69156038

研究负责人电话:

Study leader's
telephone:

+86 10 69156038

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:

429087257@qq.com

研究负责人电子邮件:

Study leader's E-mail:

wuwm@pumch.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:

北京市东城区帅府园1号

研究负责人通讯地址:

北京市东城区帅府园1号

Applicant address:

No. 1, Shuaifuyuan, Dongcheng District, Beijing

Study leader's address:

No. 1, Shuaifuyuan, Dongcheng District, Beijing

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:

中国医学科学院北京协和医院

Applicant's institution:

Peking Union Medical College Hospital

研究负责人所在单位:

中国医学科学院北京协和医院

Affiliation of the Leader:

Peking Union Medical College Hospital

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:

I-26PJ0284

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:

中国医学科学院北京协和医院伦理审查委员会

Name of the ethic committee:

PUMCH Institutional Review Board

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-28 00:00:00

伦理委员会联系人:

李佳月

Contact Name of the ethic committee:

Jiayue Li

伦理委员会联系地址:

北京市东城区帅府园1号

Contact Address of the ethic committee:

No. 1, Shuaifuyuan, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 69156874

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dott1994@163.com

研究实施负责(组长)单位:

中国医学科学院北京协和医院

Primary sponsor:

Peking Union Medical College Hospital

研究实施负责(组长)单位地址:

北京市东城区帅府园1号

Primary sponsor's address:

No. 1, Shuaifuyuan, Dongcheng 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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院北京协和医院

具体地址:

北京市东城区帅府园1号

Institution
hospital:

Peking Union Medical College Hospital

Address:

No. 1, Shuaifuyuan, Dongcheng District, Beijing

经费或物资来源:

临研专项-重点培育

Source(s) of funding:

Special Research Project – Major

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:

连续入组 

Study design:

Sequential 

研究目的:

本项目聚焦胰腺癌恶病质诊断的关键临床挑战,针对早期预警不足(Pre-cachexia期漏诊率>50%)的核心问题开展相关研究。项目将构建前瞻性、观察性队列研究(非干预性,仅收集数据及样本)  

Objectives of Study:

This project focuses on the key clinical challenges in diagnosing pancreatic cancer cachexia. It aims to conduct research addressing the core issue of inadequate early warning (overall misdiagnosis rate in the pre-cachexia phase >50%). The project will establish a prospective, observational cohort study (non-interventional, solely collecting data and samples).

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.合并其他恶性肿瘤或严重精神疾病; 2.妊娠期女性或无法配合随访者。

Exclusion criteria:

1. Comorbidity with other malignant tumors or severe mental illnesses. 2. Women during pregnancy or those who are unable to participate in follow-up visits.

研究实施时间:

Study execute time:

From 2025-08-01 00:00:00 To 2028-07-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-24 00:00:00 To 2028-07-31 00:00:00

干预措施:

Interventions:

组别:

恶病质组

样本量:

300

Group:

Cachexia group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

前恶病质组

样本量:

200

Group:

Pre-cachexia 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):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院北京协和医院 

单位级别:

三级甲等 

Institution
hospital:

Peking Union Medical College Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

总体生存期

指标类型:

主要指标

Outcome:

Overall survival

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无恶病质生存期

指标类型:

次要指标

Outcome:

Cachexia-free survival

Type:

Secondary 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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

标本中文名:

肿瘤标本

组织:

Sample Name:

tumor samples

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

标本中文名:

粪便

组织:

Sample Name:

feces

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 18 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

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):

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

None

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-04-15 16:15:31