ChiCTR2300078129 版本V1.1 版本创建时间2024/07/20 13:56:02 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300078129 

最近更新日期：

Date of Last Refreshed on：

2023-11-29 11:39:28 

注册时间：

Date of Registration：

2023-11-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

機器學習方法確定視網膜特徵以進行血紅素篩選的驗證研究

Public title：

Validation for haemoglobin screening using a machine-learning approach with retinal characteristics

注册题目简写：

English Acronym：

研究课题的正式科学名称：

機器學習方法確定視網膜特徵以進行血紅素篩選的驗證研究

Scientific title：

Validation for haemoglobin screening using a machine-learning approach with retinal characteristics

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：

Maria LAI 

研究负责人：

Dr. Tsin-Wah Leung 

Applicant：

Maria LAI 

Study leader：

Dr. Tsin-Wah Leung 

申请注册联系人电话：

Applicant telephone：

+852 2252 8865

研究负责人电话：

Study leader's telephone：

+852 4658 7258

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：

marialai@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

leungtw2@ha.org.hk

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：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin, N.T., Hong Kong, China

研究负责人通讯地址：

25 Waterloo Road, Yaumatei, Kowloon, Hong Kong

Applicant address：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin, N.T., Hong Kong, China

Study leader's address：

25 Waterloo Road, Yaumatei, Kowloon, Hong Kong

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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

Kwong Wah Hospital

Affiliation of the Leader：

Kwong Wah Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KC/KE-23-0127/ER-1

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：

Kowloon Central / Kowloon East Research Ethics Committee

Name of the ethic committee：

Kowloon Central / Kowloon East Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023-11-07 00:00:00

伦理委员会联系人：

Dr. KWAN Chung Kong

Contact Name of the ethic committee：

Dr. KWAN Chung Kong

伦理委员会联系地址：

c/o Queen Elizabeth Hospital, 30 Gascoigne Road Kowloon

Contact Address of the ethic committee：

c/o Queen Elizabeth Hospital, 30 Gascoigne Road Kowloon

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3506 8888

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：

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

Primary sponsor：

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

研究实施负责（组长）单位地址：

25 Waterloo Road, Yaumatei, Kowloon, Hong Kong

Primary sponsor's address：

25 Waterloo Road, Yaumatei, Kowloon, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Kwong Wah Hospital

具体地址：

25 Waterloo Road, Yaumatei, Kowloon, Hong Kong

Institution
hospital：

Kwong Wah Hospital

Address：

25 Waterloo Road, Yaumatei, Kowloon, Hong Kong

经费或物资来源：

N/A

Source(s) of funding：

N/A

Target disease：

anaemia

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：

Primary 1. To confirm the retinal image characteristics significantly associated with anaemia using the machine-learning method. Secondary 2. To validate the final classification model for anaemia based on a machine-learning approach and a specific set of retinal characteristics.  

Objectives of Study：

Primary 1. To confirm the retinal image characteristics significantly associated with anaemia using the machine-learning method. Secondary 2. To validate the final classification model for anaemia based on a machine-learning approach and a specific set of retinal characteristics.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Age>/=18. Haemoglobin result is ≤ 8 g/dL and can have the retinal image captured within 7 days from the blood test. Willing to sign the informed consent. Willing to comply with procedures required in the protocol.

Inclusion criteria

Age>/=18. Haemoglobin result is ≤ 8 g/dL and can have the retinal image captured within 7 days from the blood test. Willing to sign the informed consent. Willing to comply with procedures required in the protocol.

排除标准：

Poor retinal images quality that cannot be used in the analysis. Subjects with other eye diseases are unsuitable for retinal imaging, such as severe cataracts, glaucoma, atretopsia, and corneal plague. Subjects are distressed with a flashlight or have experience with photosensitive seizures. Unwillingness or inability to comply with procedures required in the protocol.

Exclusion criteria：

Poor retinal images quality that cannot be used in the analysis. Subjects with other eye diseases are unsuitable for retinal imaging, such as severe cataracts, glaucoma, atretopsia, and corneal plague. Subjects are distressed with a flashlight or have experience with photosensitive seizures. Unwillingness or inability to comply with procedures required in the protocol.

研究实施时间：

Study execute time：

从 From 2023-12-01 00:00:00至 To 2025-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-12-01 00:00:00 至 To 2024-11-30 00:00:00  

干预措施：

Interventions：

组别：

anaemia subjects

样本量：

80

Group：

anaemia subjects

Sample size：

干预措施：

N/A

干预措施代码：

 N/A

Intervention：

N/A

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

Kwong Wah Hospital 

单位级别：

N/A 

Institution
hospital：

Kwong Wah Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

retinal vessels parameters

指标类型：

主要指标

Outcome：

retinal vessels parameters

Type：

Primary indicator

测量时间点：

测量方法：

automatic retinal image analysis (ARIA)

Measure time point of outcome：

Measure method：

automatic retinal image analysis (ARIA)

指标中文名：

classification model

指标类型：

次要指标

Outcome：

classification model

Type：

Secondary indicator

测量时间点：

测量方法：

Machine Learning Approach

Measure time point of outcome：

Measure method：

Machine Learning Approach

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age N/A 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

N/A

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：

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

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）：

Upon request from Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Beginning 12 months and ending 18 months following article publication.

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

Upon request from Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Beginning 12 months and ending 18 months following article publication.

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：

Case Report Form

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

Case Report Form

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：

  2023-11-29 11:38:48