Today is 2019-12-10

Identification of biomarkers for glaucoma in the tear film by next generation proteomic technology
download

注册号:

Registration number:

ChiCTR1800016582 

最近更新日期:

Date of Last Refreshed on:

2018-06-11 

注册时间:

Date of Registration:

2018-06-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

利用下一代蛋白質組學技術鑑定淚膜中青光眼的生物標誌物 

Public title:

Identification of biomarkers for glaucoma in the tear film by next generation proteomic technology 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利用下一代蛋白質組學技術鑑定淚膜中青光眼的生物標誌物 

Scientific title:

Identification of biomarkers for glaucoma in the tear film by next generation proteomic technology 

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:

CUHK_CCRB00611 

申请注册联系人:

Miss Wong Sin Ting Janice 

研究负责人:

Prof. Leung Kai Shun Christopher 

Applicant:

Miss Wong Sin Ting Janice 

Study leader:

Prof. Leung Kai Shun Christopher 

申请注册联系人电话:

Applicant telephone:

+852 39435825 

研究负责人电话:

Study leader's telephone:

+852 39435825 

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:

janicewong@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

cksleung@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/561 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/561 

申请注册联系人通讯地址:

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

研究负责人通讯地址:

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

Applicant address:

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

Study leader's address:

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

The Chinese University of Hong Kong 

Applicant's institution:

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:

CRE Ref. No. 2018.065 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

Joint CUHK-NTEC Clinical Research Ethics Committee 

Name of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-04 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

The Chinese University of Hong Kong

具体地址:

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

Institution
hospital:

The Chinese University of Hong Kong

Address:

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

经费或物资来源:

N/A 

Source(s) of funding:

N/A 

研究疾病:

青光眼 

Target disease:

glaucoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

利用下一代蛋白質組學技術鑑定淚膜中青光眼的生物標誌物 

Objectives of Study:

Identification of biomarkers for glaucoma in the tear film by next generation proteomic technology 

药物成份或治疗方案详述:

Newly diagnosed glaucoma group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours. 1. Refraction 2. Visual acuity 3. Slit lamp biomicroscopy 4. Fundus examination 5. IOP measurement 6. Central Corneal Thickness 7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT) 8. Visual field (for the newly diagnosed glaucoma participants only) When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification. Control group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours. 1. Refraction 2. Visual acuity 3. Slit lamp biomicroscopy 4. Fundus examination 5. IOP measurement 6. Central Corneal Thickness 7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT) 8. Visual field (for the newly diagnosed glaucoma participants only) When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification. Control group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours. 1. Refraction 2. Visual acuity 3. Slit lamp biomicroscopy 4. Fundus examination 5. IOP measurement 6. Central Corneal Thickness 7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT) 8. Visual field (for the newly diagnosed glaucoma participants only) When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification. 

Description for medicine or protocol of treatment in detail:

Newly diagnosed glaucoma group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours. 1. Refraction 2. Visual acuity 3. Slit lamp biomicroscopy 4. Fundus examination 5. IOP measurement 6. Central Corneal Thickness 7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT) 8. Visual field (for the newly diagnosed glaucoma participants only) When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification. Control group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours. 1. Refraction 2. Visual acuity 3. Slit lamp biomicroscopy 4. Fundus examination 5. IOP measurement 6. Central Corneal Thickness 7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT) 8. Visual field (for the newly diagnosed glaucoma participants only) When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification. Control group subjects will be recruited. Participants receive the following ocular examinations to check for eligibility for inclusion. The examinations take around 3 hours. 1. Refraction 2. Visual acuity 3. Slit lamp biomicroscopy 4. Fundus examination 5. IOP measurement 6. Central Corneal Thickness 7. Retinal Nerve Fiber L ayer RNFL measurement by Optical coherence tomography (OCT) 8. Visual field (for the newly diagnosed glaucoma participants only) When participants fulfill the inclusion criteria, a registered optometrist will collect tears sample from participants' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes. No local anaesthetics or other eye drops will be applied. Following tear collection, each sample will be placed in a clean tube and stored at -80oC for further analysis. In order to secure the identity of the subjects, a number code will be assigned for specimen identification. 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

Control group subject inclusion criteria: 1. Chinese adults aged between 40-60 years; 2. Spectacle corrected monocular VA: 0.2 logMAR or better after full correction; 3. No contact lens wear; 4. Free of ocular and systemic abnormalities e.g. cataract, diabetes mellitus (DM) Intraocular pressure (IOP): 21 mmHg or less in both eyes; 5. Difference in IOP between two eyes: 3 mmHg or less; 6. Able to give written consent. Newly diagnosed glaucoma group subject inclusion criteria: 1. Early onset of signs of primary open-angled glaucoma (POAG); 2. Intraocular pressure (IOP): 22 mmHg or more in one or both eyes; 3. Sign of optic nerve abnormalities according to the classification of Mild or Early Stage Glaucoma in the Glaucoma ICD-10 quick reference guide of the American Academy of Ophthalmology (AAO); 4. Free from other ocular and systemic diseases e.g. cataract, DM etc.; 5. Able to give written consent. 

Inclusion criteria

Control group subject inclusion criteria: 1. Chinese adults aged between 40-60 years; 2. Spectacle corrected monocular VA: 0.2 logMAR or better after full correction; 3. No contact lens wear; 4. Free of ocular and systemic abnormalities e.g. cataract, diabetes mellitus (DM) Intraocular pressure (IOP): 21 mmHg or less in both eyes; 5. Difference in IOP between two eyes: 3 mmHg or less; 6. Able to give written consent. Newly diagnosed glaucoma group subject inclusion criteria: 1. Early onset of signs of primary open-angled glaucoma (POAG); 2. Intraocular pressure (IOP): 22 mmHg or more in one or both eyes; 3. Sign of optic nerve abnormalities according to the classification of Mild or Early Stage Glaucoma in the Glaucoma ICD-10 quick reference guide of the American Academy of Ophthalmology (AAO); 4. Free from other ocular and systemic diseases e.g. cataract, DM etc.; 5. Able to give written consent. 

排除标准:

1. Regular contact lens wear; 2. DM, severe heart disease, history of stroke; 3. Dry eye disease; 4. Underwent LASIK surgery. 

Exclusion criteria:

1. Regular contact lens wear; 2. DM, severe heart disease, history of stroke; 3. Dry eye disease; 4. Underwent LASIK surgery. 

研究实施时间:

Study execute time:

FromTo  

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

Using ProteinPilot 5.0 software

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Using ProteinPilot 5.0 software

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

Different protein expressions

Index test:

Different protein expressions

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

glaucoma

例数:

Sample size:

14

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

glaucoma

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

Chinese adults aged between 40-60 years

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Chinese adults aged between 40-60 years

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Differentially protein expressions

指标类型:

主要指标 

Outcome:

Differentially protein expressions

Type:

Primary indicator 

测量时间点:

21 months

测量方法:

Using ProteinPilot 5.0 software

Measure time point of outcome:

21 months

Measure method:

Using ProteinPilot 5.0 software

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

Blood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 60 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

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-06-01
return list