TL1A在结直肠癌中的表达及意义的相关性研究

注册号:

Registration number:

ChiCTR2600121585 

最近更新日期:

Date of Last Refreshed on:

2026-04-01 10:22:58 

注册时间:

Date of Registration:

2026-04-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

TL1A在结直肠癌中的表达及意义的相关性研究

Public title:

Expression of TL1A in Colorectal Cancer and a Correlative Study of Its Significance

注册题目简写:

English Acronym:

研究课题的正式科学名称:

TL1A在结直肠癌中的表达及意义的相关性研究

Scientific title:

Expression of TL1A in Colorectal Cancer and a Correlative Study of Its Significance

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:

祝思慧 

研究负责人:

祝思慧 

Applicant:

Zhu Sihui 

Study leader:

Zhu Sihui 

申请注册联系人电话:

Applicant telephone:

+86 15700098468

研究负责人电话:

Study leader's
telephone:

+86 571 8616 3537

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:

673979453@qq.com

研究负责人电子邮件:

Study leader's E-mail:

673979453@qq.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:

杭州市临平区临平街道保健路60号

研究负责人通讯地址:

杭州市临平区临平街道保健路60号

Applicant address:

No. 60, Health Care Road, Linping Street, Linping District, Hangzhou City

Study leader's address:

No. 60, Health Care Road, Linping Street, Linping District, Hangzhou 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:

杭州市临平区中西医结合医院

Applicant's institution:

Hangzhou Linping District Integrated Traditional Chinese and Western Medicine Hospital

研究负责人所在单位:

杭州市临平区中西医结合医院

Affiliation of the Leader:

Hangzhou Linping Hospital of Integrated Traditional Chinese and Western 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:

临中西医伦审2026研第004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:

杭州市临平区中西医结合医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Hangzhou Linping Hospital of Integrated Traditional Chinese And Western Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2026-03-20 00:00:00

伦理委员会联系人:

苑修源

Contact Name of the ethic committee:

Xiuyuan Yuan

伦理委员会联系地址:

杭州市临平区临平街道保健路60号

Contact Address of the ethic committee:

No. 60, Health Care Road, Linping Street, Linping District, Hangzhou City

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 571 86163116

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ywykjk@163.com

研究实施负责(组长)单位:

杭州市临平区中西医结合医院

Primary sponsor:

Hangzhou Linping Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责(组长)单位地址:

杭州市临平区临平街道保健路60号

Primary sponsor's address:

No. 60, Health Care Road, Linping Street, Linping District, Hangzhou 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州市临平区中西医结合医院

具体地址:

杭州市临平区临平街道保健路60号

Institution
hospital:

Hangzhou Linping Hospital of Integrated Traditional Chinese and Western Medicine

Address:

No. 60, Health Care Road, Linping Street, Linping District, Hangzhou City

经费或物资来源:

临平区医疗科技项目

Source(s) of funding:

Linping District Medical Technology Project

研究疾病:

结直肠癌  

Target disease:

colorectal 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:

明确TL1A在结直肠癌组织与正常肠道黏膜中的表达差异,揭示TL1A表达水平与结直肠癌患者临床及病理特征(如肿瘤分期、浸润深度、淋巴结转移等)之间的关系,评估TL1A作为结直肠癌潜在生物标志物的临床价值,为结直肠癌的早期诊断、预后评估及靶向治疗提供新的理论依据和研究方向。  

Objectives of Study:

To clarify the differential expression of TL1A in colorectal cancer tissues and normal intestinal mucosa, to reveal the relationship between TL1A expression levels and the clinical and pathological characteristics of colorectal cancer patients (such as tumor stage, depth of invasion, lymph node metastasis, etc.), to evaluate the clinical value of TL1A as a potential biomarker for colorectal cancer, and to provide a new theoretical basis and research direction for the early diagnosis, prognostic assessment, and targeted therapy of colorectal cancer.

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.健康人群未行全结肠镜检查,即内镜未到达回盲部。
2.有合并其他肿瘤、血液病、严重肝肾功能不全以及严重疾病或基础疾病较多等的患者。
3.经放化疗治疗或在近期的3个月内参加临床试验者。
4.由其他原因引起的精神障碍者。
5.患者信息和临床资料不全、数据不完整及失联患者。

Exclusion criteria:

1.A complete colonoscopy was not performed on the healthy subjects, with the endoscope not reaching the ileocecal region.
2.Patients with other concurrent tumors, hematological diseases, severe hepatic or renal insufficiency, severe diseases, or multiple underlying diseases.
3.Patients who have received radiotherapy or chemotherapy, or have participated in clinical trials in the past 3 months.
4.Patients with mental disorders caused by other reasons.
5.Patients with incomplete personal information or clinical data, incomplete data, and those lost to follow-up.

研究实施时间:

Study execute time:

From 2026-04-01 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-01 00:00:00 To 2027-12-31 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

结直肠癌

样本量:

60

Group:

colorectal cancer

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):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州市临平区中西医结合医院 

单位级别:

三级 

Institution
hospital:

Hangzhou Linping Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution:

Tertiary

测量指标:

Outcomes:

指标中文名:

TL1A表达水平

指标类型:

主要指标

Outcome:

TL1A expression level

Type:

Primary indicator

测量时间点:

2027年1月1日~2027年9月30日

测量方法:

免疫组化检测

Measure time point of outcome:

January 1, 2027 – September 30, 2027

Measure method:

Immunohistochemistry test

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

肠道组织

组织:

Sample Name:

Intestinal tissue

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

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):

N/A

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:

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)。

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

Data collection and Management (Astandard data collection and management system indude a CRF and an electronic data capture.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-04-01 10:22:35