整合医学视角下未分化疾病多学科精准诊疗体系的构建与全科医学实践创新研究

注册号:

Registration number:

ChiCTR2500103272 

最近更新日期:

Date of Last Refreshed on:

2025-05-27 15:01:56 

注册时间:

Date of Registration:

2025-05-27 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

整合医学视角下未分化疾病多学科精准诊疗体系的构建与全科医学实践创新研究

Public title:

Construction of a multidisciplinary precise diagnosis and treatment system for undifferentiated diseases from the perspective of integrated medicine and innovative research on general practice practice

注册题目简写:

English Acronym:

研究课题的正式科学名称:

整合医学视角下未分化疾病多学科精准诊疗体系的构建与全科医学实践创新研究

Scientific title:

Construction of a multidisciplinary precise diagnosis and treatment system for undifferentiated diseases from the perspective of integrated medicine and innovative research on general practice practice

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:

严晓云 

研究负责人:

张清 

Applicant:

Xiaoyun Yan 

Study leader:

Qing Zhang  

申请注册联系人电话:

Applicant telephone:

+86 158 9626 7961

研究负责人电话:

Study leader's
telephone:

+86 159 9667 5119

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:

2316090962@qq.com

研究负责人电子邮件:

Study leader's E-mail:

zzhangqing32@sina.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:

江苏省南通市崇川区胜利路666号

研究负责人通讯地址:

江苏省南通市崇川区胜利路666号

Applicant address:

No. 666, Shengli Road, Chongchuan District, Nantong, Jiangsu

Study leader's address:

No. 666, Shengli Road, Chongchuan District, Nantong, Jiangsu

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:

南通市第一人民医院

Applicant's institution:

Nantong First People's Hospital

研究负责人所在单位:

南通市第一人民医院

Affiliation of the Leader:

Nantong First People's 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:

2025KT089

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:

南通市第一人民医院伦理委员会

Name of the ethic committee:

Ethics Committee of Nantong First People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2025-03-28 00:00:00

伦理委员会联系人:

徐洪青

Contact Name of the ethic committee:

Hongqing Xu

伦理委员会联系地址:

江苏省南通市崇川区胜利路666号

Contact Address of the ethic committee:

No. 666, Shengli Road, Chongchuan District, Nantong, Jiangsu

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 159 5131 2678

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:

南通市第一人民医院

Primary sponsor:

Nantong First People's Hospital

研究实施负责(组长)单位地址:

江苏省南通市崇川区胜利路666号

Primary sponsor's address:

No. 666, Shengli Road, Chongchuan District, Nantong, Jiangsu

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

南通

Country:

China

Province:

Jiangsu

City:

Nantong

单位(医院):

南通市第一人民医院

具体地址:

江苏省南通市崇川区胜利路666号

Institution
hospital:

Nantong First People's Hospital

Address:

No. 666, Shengli Road, Chongchuan District, Nantong, Jiangsu

经费或物资来源:

自筹

Source(s) of funding:

Self-raised funds

研究疾病:

未分化疾病  

Target disease:

Medically Unexplained Diseases

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:

队列研究 

Study design:

Cohort study 

研究目的:

构建以全科医学为核心、多学科协作的未分化疾病精准诊疗体系,形成"筛-评-诊-管"全流程解决方案  

Objectives of Study:

Build a precise diagnosis and treatment system for undifferentiated diseases with general practice as the core and multidisciplinary collaboration, form a full-process solution for "screening-evaluation-diagnosis-management".

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、已明确诊断疾病; 2、严重精神疾病或认知障碍; 3、妊娠或哺乳期妇女; 4、无法配合随访患者。

Exclusion criteria:

1. A clear diagnosis of the disease has been made; 2. Serious mental illness or cognitive impairment; 3. Pregnant or lactating women; 4. Unable to cooperate with follow-up patients.

研究实施时间:

Study execute time:

From 2025-04-01 00:00:00 To 2025-07-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-04-02 00:00:00 To 2025-06-30 00:00:00

干预措施:

Interventions:

组别:

未分化疾病患者组

样本量:

300

Group:

Patients with Medically Unexplained Diseases

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):

江苏 

市(区县):

南通 

Country:

China

Province:

Jiangsu

City:

Nantong

单位(医院):

南通市第一人民医院 

单位级别:

三甲 

Institution
hospital:

Nantong First People's Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

症状改善情况

指标类型:

主要指标

Outcome:

Improvement of symptoms

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:

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:

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 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:

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):

在试验结束六个月内,联系研究者邮箱获取:zzhangqing32@sina.cn。

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

Within six months after the end of the experiment, contact the researcher's email to obtain: zzhangqing32@sina.cn .

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:

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

None

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:

 2025-05-27 15:01:51