中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600117904
最近更新日期： Date of Last Refreshed on：	2026-01-29 17:49:16
注册时间： Date of Registration：	2026-01-29 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于多模态大数据的眼-脑跨器官映射与全身疾病关联研究
Public title：	Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于多模态大数据的眼-脑跨器官映射与全身疾病关联研究
Scientific title：	Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
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：	吕晗	研究负责人：	吕晗
Applicant：	LV HAN	Study leader：	Lv Han
申请注册联系人电话： Applicant telephone：	+86 10 63138625	研究负责人电话： Study leader's telephone：	+86 10 63138625
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：	chrislvhan@126.com	研究负责人电子邮件： Study leader's E-mail：	chrislvhan@126.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：	北京市西城区永安路95号	研究负责人通讯地址：	北京市西城区永安路95号
Applicant address：	No. 95 Yong'an Road, Xicheng District, Beijing	Study leader's address：	No.95 Yongan Road,Xicheng District,Beijing,China
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：	首都医科大学附属北京友谊医院
Applicant's institution：	Beijing Friendship Hospital, Capital Medical University
研究负责人所在单位：	首都医科大学附属北京友谊医院
Affiliation of the Leader：	Beijing Friendship Hospital ,Capital Medical University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2025-P2-617-01	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：	首都医科大学附属北京友谊医院科研伦理委员会
Name of the ethic committee：	Research Ethics Committee of Beijing Friendship Hospital, Capital Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-22 00:00:00
伦理委员会联系人：	李悦
Contact Name of the ethic committee：	Li Yue
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 Yongan Road,Xicheng District,Beijing,China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 63139006	伦理委员会联系人邮箱： Contact email of the ethic committee：	13661202501@163.com

研究实施负责（组长）单位：

首都医科大学附属北京友谊医院

Primary sponsor：

Beijing Friendship Hospital ,Capital Medical University

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：

No.95 Yongan Road,Xicheng District,Beijing,China

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)：	首都医科大学附属北京友谊医院	具体地址：	北京市西城区永安路95号
Institution hospital：	Beijing Friendship Hospital ,Capital Medical University	Address：	No.95 Yongan Road,Xicheng District,Beijing,China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-raised

研究疾病：

白内障、玻璃体积血、糖尿病眼病、脑小血管病、脑血管狭窄、帕金森病等。

Target disease：

Cataract, vitreous hemorrhage, diabetic eye disease, Cerebral small vessel disease, cerebrovascular stenosis, Parkinson's disease, etc.

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：

本项目通过整合5万例眼部多模态数据（CFP、OCT、OCTA）、15万例脑MR数据及8000例眼脑配对队列的ICD诊断、医嘱及检查结果，构建眼-脑跨模态映射模型与眼脑-全身疾病关联模型，明确眼部多模态特征与脑部结构与血管特征、全身疾病ICD诊断的定量关联关系，从而揭示眼脑跨器官跨模态关联机制，实现基于眼部的脑影像特征的映射和预测与眼部诊断、预测各类疾病，对疾病的早期筛查、风险分层及临床诊疗优化具有重要意义。

Objectives of Study：

This project integrates multimodal eye data (CFP, OCT, OCTA) from 50,000 cases, brain MR data from 150,000 cases, and ICD diagnoses, medical orders, and test results from an eye-brain paired cohort of 8,000 cases to construct an eye-brain cross-modal mapping model and an eye-brain-systemic disease association model. It aims to clarify the quantitative associations between multimodal ocular features and brain structural and vascular characteristics as well as systemic disease ICD diagnoses, thereby uncovering the cross-organ and cross-modal linkage mechanisms between the eye and brain. Ultimately, it seeks to achieve mapping and prediction of brain imaging features based on ocular data, enable ocular-based diagnosis and prediction of various diseases, and contribute significantly to early disease screening, risk stratification, and optimization of clinical diagnosis and treatment.

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

1.Eye data: Images must meet quality standards (no significant artifacts, key structures clearly visible), with complete examination records (including examination date and device model);
2.Brain data: MR images must be free of motion artifacts, with complete sequences (at least including T1-weighted imaging and MRA), and reports must confirm no technical issues;
3.Eye-brain paired cohort: Must contain at least one type of eye image (including CFP, OCT, or OCTA) along with brain MR data, and be linkable to a unique identifier and clinical information in the database;
4.Clinical data: Clinical information (such as core biochemical indicators, demographic information, and necessary questionnaire items) must have a missing rate ＜=30%, with standardized and clear ICD diagnostic codes, complete laboratory test data, and medical order information (including medication or follow-up recommendations);
5.Prior to initial inclusion in the study, participants must have no history of severe organic diseases (including non-curable or end-stage malignancies, severe heart failure (NYHA Class III-IV), end-stage renal disease (CKD Stage 5), decompensated cirrhosis, or significant functional impairment due to severe cerebrovascular disease sequelae, etc.).

排除标准：

1.眼部检查因白内障、玻璃体积血等导致关键特征无法识别；脑部MR因金属植入物等导致图像质量不合格。
2.临床信息（如核心生化指标、人口学信息、必要的问卷条目等）缺失>30％。
3.妊娠期或哺乳期女性、合并眼部外伤、先天性眼部畸形、有严重器质性疾病者。

Exclusion criteria：

1.Ocular examinations in which key features cannot be identified due to conditions such as cataracts or vitreous hemorrhage brain MR images deemed unacceptable in quality due to factors such as metal implants;
2.Clinical information (including core biochemical indicators, demographic details, essential questionnaire items, etc.) with a missing rate exceeding 30%;
3. Individuals who are pregnant or lactating, those with ocular trauma, congenital ocular malformations, or severe organic diseases.

研究实施时间：

Study execute time：

从 From 2026-01-23 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-29 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	观察组（眼部数据队列、脑部数据队列、眼脑配对队列、临床关联队列）	样本量：	208000
Group：	Observation group(1.Ocular Data Cohort. 2.Brain Data Cohort,. 3.Eye-Brain Paired Cohort. 4.Clinical Association Cohort.)	Sample size：	208000
干预措施：	无	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)：	首都医科大学附属北京友谊医院	单位级别：	三级甲等
Institution hospital：	Beijing Friendship Hospital ,Capital Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	眼脑映射模型性能	指标类型：	主要指标
Outcome：	Eye-Brain Mapping Model Performance	Type：	Primary indicator
测量时间点：	测量发生在研究期间构建模型和一致性比对的时刻（2026.1-2016.12）。	测量方法：
Measure time point of outcome：	Measurements were taken at the time when individuals completed their examinations at the hospital be	Measure method：

指标中文名：	全身疾病预测模型性能	指标类型：	主要指标
Outcome：	Performance of Systemic Disease Prediction Models	Type：	Primary indicator
测量时间点：	测量发生在研究期间构建模型和一致性比对的时刻（2026.1-2016.12）。	测量方法：
Measure time point of outcome：	Measurements were taken at the time when individuals completed their examinations at the hospital be	Measure method：

指标中文名：	单器官模型特征提取准确性	指标类型：	主要指标
Outcome：	Clinical and Diagnostic Indicators	Type：	Primary indicator
测量时间点：	测量发生在研究期间构建模型和一致性比对的时刻（2026.1-2016.12）。	测量方法：
Measure time point of outcome：	Measurements were taken at the time when individuals completed their examinations at the hospital be	Measure method：

指标中文名：	不同疾病亚组关联强度	指标类型：	主要指标
Outcome：	Strength of association across disease subgroups	Type：	Primary indicator
测量时间点：	测量发生在研究期间构建模型和一致性比对的时刻（2026.1-2016.12）。	测量方法：
Measure time point of outcome：	Measurements were taken at the time when individuals completed their examinations at the hospital be	Measure method：

指标中文名：	模型泛化能力	指标类型：	主要指标
Outcome：	Model generalisation capability	Type：	Primary indicator
测量时间点：	测量发生在研究期间构建模型和一致性比对的时刻（2026.1-2016.12）。	测量方法：
Measure time point of outcome：	Measurements were taken at the time when individuals completed their examinations at the hospital be	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	0	岁 years
最大 Max age		岁 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）：

无

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：	无
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）：	通过友谊医院临床医学大数据平台进行数据分享。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Data sharing is conducted via the Clinical Medical Big Data Platform of Beijing Friendship Hospital.
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：	研究所有信息均通过临床大数据平台导出后，由完全独立的第三方专业加密人员进行脱敏（去标识化）及加密处理，该第三方人员仅负责数据加密并设置访问密码，不参与后续任何研究流程，且与本研究团队无任何隶属或合作关系，确保其不会接触或利用研究数据。脱敏加密后的数据中不包含可识别受试者身份的姓名、手机号、身份证号、登记号等信息，根据所获得的信息无法联系到受试者，因此申请免除知情同意。本研究为纯科学研究，旨在探索眼-脑-全身疾病关联，无任何商业转化计划或商业利益关联。若未来基于本研究模型开发的应用涉及商业转化，将重新提交伦理审查申请并严格遵守知情同意要求。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	All study information is exported through the clinical big data platform and then undergoes de-identification (anonymization) and encryption processing by a completely independent third-party professional encryption specialist. This third-party specialist is solely responsible for data encryption and setting access passwords and does not participate in any subsequent research processes. Furthermore, this specialist has no affiliation or cooperative relationship with the research team, ensuring that they neither access nor utilize the research data. The de-identified and encrypted data does not contain any information that could identify participants, such as names, phone numbers, ID numbers, or registration numbers. Based on the information obtained, it is impossible to contact the participants. Therefore, an exemption from informed consent is requested. This study is purely scientific research aimed at exploring the associations between eye-brain-systemic diseases and has no commercial translation plans or commercial interests. If any future applications developed based on this research model involve commercial translation, a new ethical review application will be submitted, and informed consent requirements will be strictly adhered to.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-01-29 17:49:06