靶向CD34+ CAFs中TGF-β-AGR2轴:一项探索其在胰腺癌进展中作用与临床意义的转化研究

注册号:

Registration number:

ChiCTR2600123658 

最近更新日期:

Date of Last Refreshed on:

2026-04-28 16:19:51 

注册时间:

Date of Registration:

2026-04-28 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

靶向CD34+ CAFs中TGF-β-AGR2轴:一项探索其在胰腺癌进展中作用与临床意义的转化研究

Public title:

The TGF-β-AGR2 Axis in Targeted CD34+ CAFs: A Translational Study Exploring Its Role and Clinical Significance in Pancreatic Cancer Progression

注册题目简写:

English Acronym:

研究课题的正式科学名称:

CD34-TGFβ-AGR2轴在胰腺癌中的作用机制研究

Scientific title:

Mechanistic studies on the role of the CD34-TGFβ-AGR2 axis 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:

胡婷 

研究负责人:

陈伟庆 

Applicant:

Ting Hu 

Study leader:

Weiqing Chen 

申请注册联系人电话:

Applicant telephone:

+86 157 3609 5062

研究负责人电话:

Study leader's
telephone:

+86 139 8369 5334

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:

ht19960926@126.com

研究负责人电子邮件:

Study leader's E-mail:

chenwq620712@163.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Chongqing University Affiliated Cancer Hospital

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:

重庆市沙坪坝区渝碚路131号重大c区

研究负责人通讯地址:

重庆市沙坪坝区汉渝路181号

Applicant address:

No. 131, Yubei Road, Chongqing University C District, Shapingba District, Chongqing City.

Study leader's address:

181 Hanyu Road, Shapingba District, Chongqing City.

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:

重庆大学医学院

Applicant's institution:

Chongqing University School of Medicine

研究负责人所在单位:

重庆大学附属肿瘤医院

Affiliation of the Leader:

The Cancer Hospital Affiliated to Chongqing University

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:

CZLL2025-120-001

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:

重庆大学附属肿瘤医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Cancer Hospital Affiliated to Chongqing University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-12-03 00:00:00

伦理委员会联系人:

汤晓华

Contact Name of the ethic committee:

Xiaohua Tang

伦理委员会联系地址:

重庆市沙坪坝区汉渝路 181 号

Contact Address of the ethic committee:

181 Hanyu Road, Shapingba District, Chongqing City.

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 195 3993 7589

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:

重庆大学附属肿瘤医院

Primary sponsor:

The Cancer Hospital Affiliated to Chongqing University

研究实施负责(组长)单位地址:

重庆市沙坪坝区汉渝路 181 号

Primary sponsor's address:

181 Hanyu Road, Shapingba District, Chongqing City.

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属肿瘤医院

具体地址:

重庆市沙坪坝区汉渝路 181 号

Institution
hospital:

The Cancer Hospital Affiliated to Chongqing University

Address:

181 Hanyu Road, Shapingba District, Chongqing City.

经费或物资来源:

研究生课题

Source(s) of funding:

Graduate research topic

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:

探索性研究/预试验 

Study phase:

0

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

我们旨在通过单细胞测序技术,重点关注PDAC肿瘤微环境中CD34+成纤维细胞的功能,探究CD34-TGFβ-AGR2 在 PDAC 发生和转移中的作用及具体机制,明确其对 PDAC发生及转移的影响,为临床研究提供理论基础,改善患者预后。  

Objectives of Study:

Our aim is to explore the role and specific mechanism of CD34-TGFβ-AGR2 in the occurrence and metastasis of PDAC, clarify its influence on the occurrence and metastasis of PDAC, provide a theoretical basis for clinical research, and improve the prognosis of patients.

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.技术上不可实施 EUS-FNB。 2.超声内镜检查下未发现实体病变。 3.不能暂停的抗凝剂或抗血小板治疗。 4.严重凝血功能障碍。 5.禁忌的其他医疗条件。 6.孕妇或精神障碍患者等弱势群体。

Exclusion criteria:

1. EUS-FNB is technically not feasible. 2. No solid lesions were detected during the endoscopic ultrasound examination. 3. Anticoagulant or antiplatelet therapy that cannot be discontinued. 4. Severe coagulation dysfunction. 5. Other contraindicated medical conditions. 6. Vulnerable groups such as pregnant women or patients with mental disorders.

研究实施时间:

Study execute time:

From 2026-05-01 00:00:00 To 2026-05-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-05-01 00:00:00 To 2026-05-01 00:00:00

干预措施:

Interventions:

组别:

肿瘤组

样本量:

3

Group:

Tumor group

Sample size:

干预措施:

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

重庆 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属肿瘤医院 

单位级别:

三甲 

Institution
hospital:

The Cancer Hospital Affiliated to Chongqing University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

cd34+成纤维细胞

指标类型:

主要指标

Outcome:

CD34+ fibroblasts

Type:

Primary indicator

测量时间点:

测量方法:

单细胞测序

Measure time point of outcome:

Measure method:

Single-cell sequencing

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

其它  

说明

用于单细胞测序

Fate of sample:

0thers  

Note:

Used for single-cell sequencing

标本中文名:

胰腺癌组织

组织:

Sample Name:

Pancreatic cancer tissue

Tissue:

人体标本去向

其它  

说明

用于单细胞测序

Fate of sample:

0thers  

Note:

Used for single-cell sequencing

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 25 years
最大 Max age 65 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):

No

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:

Blinding:

None

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

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):

预计公开原始数据日期2027/12/20 采用网络平台

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

Utilize online platforms

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

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

Case Record Form(CRF)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-04-28 16:19:32