Analysis of tongue characterization and construction of diagnostic model based on machine learning in the process of inflammation-cancer transformation of gastric precancerous lesions

注册号:

Registration number:

ITMCTR2025000196

最近更新日期:

Date of Last Refreshed on:

2025-01-26

注册时间:

Date of Registration:

2025-01-26

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

基于机器学习的胃癌前病变“炎-癌转化”过程舌象特征分析与诊断模型构建研究

Public title:

Analysis of tongue characterization and construction of diagnostic model based on machine learning in the process of inflammation-cancer transformation of gastric precancerous lesions

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于机器学习的胃癌前病变“炎-癌转化”过程舌象特征分析与诊断模型构建研究

Scientific title:

Analysis of tongue characterization and construction of diagnostic model based on machine learning in the process of inflammation-cancer transformation of gastric precancerous lesions

研究课题的正式科学名称简写:

Scientific title acronym:

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:

刘坤静

研究负责人:

董宁宁

Applicant:

Kunjing Liu

Study leader:

Ningning Dong

申请注册联系人电话:

Applicant telephone:

1786419011

研究负责人电话:

Study leader's telephone:

15210609987

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:

liukunjing0127@163.com

研究负责人电子邮件:

Study leader's E-mail:

dongnn83@163.com

申请单位网址(自愿提供):

Study leader's 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:

北京市房山区阳光南大街与白杨东路交叉口东北角

研究负责人通讯地址:

北京市西城区永安路95号

Applicant address:

The northeast corner of the intersection of Yangguang South Street and Baiyang East Road Fangshan District Beijing.

Study leader's address:

No. 95 Yong'an Road Xicheng 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:

北京中医药大学

Applicant's institution:

Beijing University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

BFHHZS20240085

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

首都医科大学附属北京友谊医院学术委员会

Name of the ethic committee:

Academic Committee of Beijing Friendship Hospital Capital Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/1 0:00:00

伦理委员会联系人:

李悦

Contact Name of the ethic committee:

Yue Li

伦理委员会联系地址:

北京市西城区永安路95号

Contact Address of the ethic committee:

No. 95 Yong'an Road Xicheng District Beijing.

伦理委员会联系人电话:

Contact phone of the ethic committee:

0086-10-63139047

伦理委员会联系人邮箱:

Contact email of the ethic committee:

bjjf005@163.com

研究实施负责(组长)单位:

北京友谊医院

Primary sponsor:

Beijing Friendship Hospital

研究实施负责(组长)单位地址:

北京市西城区永安路95号

Primary sponsor's address:

95 Yongan Road Xicheng 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京友谊医院

具体地址:

北京市西城区永安路95号

Institution
hospital:

Beijing Friendship Hospital

Address:

95 Yongan Road Xicheng District Beijing

经费或物资来源:

自筹经费

Source(s) of funding:

self-financing

研究疾病:

胃癌前病变

研究疾病代码:

Target disease:

Precancerous Lesions Of Gastric Cancer

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

其它

Others

研究目的:

在本研究中,拟收集1200例内镜中心胃镜患者舌象,结合其胃镜报告或病理组织学诊断、胃肠道症状、年龄、性别、BMI等临床信息建立人工智能深度学习模型,评价舌象在胃癌前病变诊断中的价值,为中医舌象诊断理论提供科学依据,为筛查和早期检测GC提供最具成本效益、非侵入性和可接受的方法,并产生较为良好的社会经济效应。

Objectives of Study:

In this study, we plan to collect tongue images from 1200 endoscopy patients at the endoscopy center, and combine them with their gastroscopy reports or pathological tissue diagnoses, gastrointestinal symptoms, age, gender, BMI, and other clinical information to establish an artificial intelligence deep learning model. This model aims to evaluate the value of tongue images in the diagnosis of precancerous gastric lesions, provide scientific evidence for the theory of traditional Chinese medicine tongue diagnosis, and offer the most cost-effective, non-invasive, and acceptable methods for screening and early detection of gastric cancer (GC). Furthermore, it is expected to generate significant socio-economic benefits.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.患者年龄在18岁及以上; 2.接受电子内镜检查,必要时进行病理组织学检查; 3.临床诊断或病理组织学符合慢性胃炎或原发性胃癌的诊断标准。

Inclusion criteria

1.Patients must be 18 years of age or older; 2.Undergo electronic endoscopy examination and pathological tissue examination when necessary; 3.Clinical diagnosis or pathological histology conforms to the diagnostic criteria for chronic gastritis or primary gastric cancer.

排除标准:

1.患有严重的基础疾病(如冠心病、肝病、肾病或精神疾病等); 2.妊娠或哺乳期妇女; 3.近期服用铋剂或其他染色药物。

Exclusion criteria:

1.Suffering from severe underlying diseases (such as coronary heart disease liver disease kidney disease or mental disorders etc.); 2.Pregnant or lactating women; 3.Recently took bismuth agents or other staining drugs.

研究实施时间:

Study execute time:

From 2024-04-01

To      2025-04-30

征募观察对象时间:

Recruiting time:

From 2024-12-01

To      2025-04-30

干预措施:

Interventions:

组别:

观察组

样本量:

1200

Group:

Observation group

Sample size:

干预措施:

无任何干预措施

干预措施代码:

Intervention:

No intervention measures

Intervention code:

样本总量 Total sample size : 1200

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京友谊医院

单位级别:

三级甲等综合医院

Institution/hospital:

Beijing Friendship Hospital

Level of the institution:

Class III Class A general hospital

测量指标:

Outcomes:

指标中文名:

舌图

指标类型:

主要指标

Outcome:

Tongue diagram

Type:

Primary indicator

测量时间点:

横断面研究开始的当天

测量方法:

舌象仪拍摄照片

Measure time point of outcome:

The day the cross-sectional study began

Measure method:

The tongue imager takes pictures

指标中文名:

基本信息及生活习惯问卷

指标类型:

次要指标

Outcome:

Basic information and lifestyle questionnaire

Type:

Secondary indicator

测量时间点:

横断面研究开始的当天

测量方法:

向参与者提问

Measure time point of outcome:

The day the cross-sectional study began

Measure method:

Ask the participants questions

指标中文名:

胃镜病理报告

指标类型:

主要指标

Outcome:

Gastroscopic pathology report

Type:

Primary indicator

测量时间点:

胃镜检查结束后获得

测量方法:

记录参与者的病理报告

Measure time point of outcome:

Obtained at the end of the gastroscopy

Measure method:

Pathology reports of participants were recorded

指标中文名:

肿瘤标志物

指标类型:

附加指标

Outcome:

Tumor marker

Type:

Additional indicator

测量时间点:

胃镜检查前由医师评估是否需要检查,本研究只采集化验结果,不额外做任何检查

测量方法:

记录参与者的化验报告

Measure time point of outcome:

The need for examination was assessed by the physician before the gastroscopy. In this study only laboratory results were collected without any additional examination

Measure method:

Record the laboratory reports of the participants

指标中文名:

血常规

指标类型:

附加指标

Outcome:

Blood routine examination

Type:

Additional indicator

测量时间点:

胃镜检查前必查指标

测量方法:

记录参与者的化验报告

Measure time point of outcome:

Indicators must be checked before gastroscopy

Measure method:

Record the laboratory reports of the participants

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

Nothing

Tissue:

Nothing

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究根据患者胃镜活检病理诊断进行分组,属于观察性研究,不进行干预,不进行随机分组。

Randomization Procedure (please state who generates the random number sequence and by what method):

The study groups patients based on their gastroscopy biopsy pathological diagnosis. It is an observational study without intervention and does not involve randomization.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

共享日期暂定为2026.06.30,待相关成果公开发表之后若需要原始数据可联系研究者共享原始数据。

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

The tentative date for data sharing is June 30, 2026. After the related results are publicly published, if there is a need for raw data, researchers can be contacted to share the original data.

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:

数据采集和管理通过病例记录表、舌图、Excel表格等方式整理汇总。

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

Data collection and management are organized and summarized through methods such as case report forms tongue images and Excel spreadsheets.

数据管理委员会:

Data Managemen Committee:

No

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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