ChiCTR2300067256 版本V1.0 版本创建时间2023/01/01 21:43:00 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：

 ChiCTR2300067256 

最近更新日期：

Date of Last Refreshed on：

 2023-01-01 21:42:48 

注册时间：

Date of Registration：

 2023-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

探索基因組中端粒體長度及拷貝數變異作為原發性開角型青光眼發生及發展的生物學標記

Public title：

New Genomic Biomarkers for Primary Open-angle glaucoma and its progression – Telomere length and Copy Number Variants

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探索基因組中端粒體長度及拷貝數變異作為原發性開角型青光眼發生及發展的生物學標記

Scientific title：

New Genomic Biomarkers for Primary Open-angle glaucoma and its progression – Telomere length and Copy Number Variants

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：

Ms Jennifer Tsoi 

研究负责人：

譚智勇教授 

Applicant：

Ms Jennifer Tsoi 

Study leader：

Prof Tham Chee Yung Clement 

申请注册联系人电话：

Applicant telephone：

 +852 39435818

研究负责人电话：

Study leader's
telephone：

+85239435823

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：

 jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 clemtham@cuhk.edu.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：

香港九龍亞皆老街147K號香港眼科醫院3樓

研究负责人通讯地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, 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：

香港中文大學眼科及視覺科學學系

Applicant's institution：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學眼科及視覺科學學系

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

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：

 KC/KE-22-0162/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：

九龍中及九龍東聯網臨床研究倫理委員會

Name of the ethic committee：

Research Ethics Committee (Kowloon Central / Kowloon East)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-02 00:00:00

伦理委员会联系人：

Ms Lyon Chan

Contact Name of the ethic committee：

Ms Lyon Chan

伦理委员会联系地址：

香港九龍加士居道30號伊利沙伯醫院護士宿舍4樓414室

Contact Address of the ethic committee：

Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

香港中文大學眼科及視覺科學學系；研究資助局

Primary sponsor：

Department of Ophthalmology and Visual Sciences, CUHK; Research Grants Council

研究实施负责（组长）单位地址：

香港九龍亞皆老街147K號香港眼科醫院4樓; 香港灣仔港灣道6-8號瑞安中心7樓

Primary sponsor's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong; 7/F, Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大學眼科及視覺科學學系

具体地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Institution
hospital：

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong

Address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

经费或物资来源：

研究資助局優配研究金2022/23

Source(s) of funding：

Research Grants Council - General Research Fund 2022/23

研究疾病：

原發性開角型青光眼  

Target disease：

Primary Open-angle glaucoma

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：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

1. 在橫斷面分析中確認較長端粒體與POAG的關聯。 2. 確定3年內端粒體長度變化與POAG進展的關聯。 3. 確認在我們最近的基因組研究中檢測到的拷貝數變異（CNV），並確定基因組中新的CNV與POAG的敏感度和進展的關聯。 4. 評估端粒體長度和全基因組CNV與POAG內表型的關聯。 5. 評估人類基因組中基因變異與POAG的關聯。  

Objectives of Study：

1. To confirm the association of longer telomere length with primary open-angle glaucoma (POAG) in cross-sectional analysis. 2. To determine the association of changes in telomere length with POAG progression over 3 years. 3. To confirm the copy number variants (CNVs) detected in our recent genomic investigations and identify new CNVs in the genome for their associations with the susceptibility and progression of POAG, with a view to assess CNVs as an independent genetic biomarker for POAG. 4. To evaluate the associations of telomere lengths and genome-wide CNVs with the endophenotypes of POAG, including intraocular pressure, visual defects, and retinal nerve fiber layer thickness. 5. To evaluate the association of gene variants in the human genome with POAG.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

POAG subjects:
- Aged 40-80
- Diagnosed with POAG as defined by:
(1) open anterior chamber angle (i.e., Shaffer's grade III or IV on dark-room gonioscopy without indentation);
(2) characteristic glaucomatous optic disc changes (i.e., notching or hemorrhage at the neuroretinal rim, narrowed neuroretinal rim and enlarged VCDR) and RNFL defects with corresponding visual field (VF) loss as shown by the Glaucoma Hemifield Test in at least one eye;
(3) absence of identifiable causes for the glaucomatous optic neuropathy, such as previous trauma, steroids use, uveitis, or rubeosis iridis; and
(4) confirmed to have no diseases associated with TL shortening: any cancer, cardiovascular disease or type 2 diabetes.

Control subjects:
- Aged 40-80
- Normal visual acuity
- No major ocular disorders except for mild senile cataract or refractive errors, if any
- IOP below 21 mmHg

Inclusion criteria

POAG subjects:
- Aged 40-80
- Diagnosed with POAG as defined by:
(1) open anterior chamber angle (i.e., Shaffer's grade III or IV on dark-room gonioscopy without indentation);
(2) characteristic glaucomatous optic disc changes (i.e., notching or hemorrhage at the neuroretinal rim, narrowed neuroretinal rim and enlarged VCDR) and RNFL defects with corresponding visual field (VF) loss as shown by the Glaucoma Hemifield Test in at least one eye;
(3) absence of identifiable causes for the glaucomatous optic neuropathy, such as previous trauma, steroids use, uveitis, or rubeosis iridis; and
(4) confirmed to have no diseases associated with TL shortening: any cancer, cardiovascular disease or type 2 diabetes.

Control subjects:
- Aged 40-80
- Normal visual acuity
- No major ocular disorders except for mild senile cataract or refractive errors, if any
- IOP below 21 mmHg

排除标准：

Diseases associated with TL shortening such as cancer, cardiovascular disease and type 2 diabetes

Exclusion criteria：

Diseases associated with TL shortening such as cancer, cardiovascular disease and type 2 diabetes

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2025-09-30 00:00:00

干预措施：

Interventions：

组别：

POAG患者组

样本量：

 300

Group：

POAG subjects group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

對照組

样本量：

 100

Group：

Control group

Sample size：

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)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港眼科醫院 

单位级别：

 无 

Institution
hospital：

Hong Kong Eye Hospital

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港中文大學眼科中心 

单位级别：

 无 

Institution
hospital：

Chinese University of Hong Kong Eye Centre

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

基因组中与POAG风险和进展相关的TL和CNVs

指标类型：

主要指标

Outcome：

TL and CNVs in the genome that are associated with POAG risk and progression

Type：

Primary indicator

测量时间点：

每4-6個月共3年跟進

测量方法：

透過抽血和眼科檢查作關聯性分析

Measure time point of outcome：

Every 4-6 months for 3 years

Measure method：

Association analysis by blood taking and eye examination

指标中文名：

POAG相关参数与TL/CNVs的相关性

指标类型：

次要指标

Outcome：

Correlations between POAG-related parameters and TL/CNVs

Type：

Secondary indicator

测量时间点：

每4-6個月共3年跟進

测量方法：

抽血和眼科檢查

Measure time point of outcome：

Every 4-6 months for 3 years

Measure method：

Blood taking and eye examination

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

 使用后保存  

说明

保存10年

Fate of sample：

Preservation after use  

Note：

10 years

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 40 岁 years
最大 Max age 80 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）：

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:

不公开/Private

盲法：

Blinding：

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）：

N/A

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：

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection.

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

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-01-01 21:42:48