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To investigate structural variations (SVs) in autism spectrum disorder (ASD) and related endophenotypes
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注册号：

Registration number：

 ChiCTR2600125751 

最近更新日期：

Date of Last Refreshed on：

 2026-05-30 18:45:09 

注册时间：

Date of Registration：

 2026-05-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

To investigate structural variations (SVs) in autism spectrum disorder (ASD) and related endophenotypes

Public title：

To investigate structural variations (SVs) in autism spectrum disorder (ASD) and related endophenotypes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

To investigate structural variations (SVs) in autism spectrum disorder (ASD) and related endophenotypes

Scientific title：

To investigate structural variations (SVs) in autism spectrum disorder (ASD) and related endophenotypes

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：

Chair Sek Ying 

研究负责人：

Chair Sek Ying 

Applicant：

Chair Sek Ying 

Study leader：

Chair Sek Ying 

申请注册联系人电话：

Applicant telephone：

 +852 3943 6225

研究负责人电话：

Study leader's
telephone：

+852 3943 6225

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：

 sychair@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 sychair@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：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

研究负责人通讯地址：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

Applicant address：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

Study leader's address：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

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 Nethersole School of Nursing, The Chinese University of Hong Kong

Applicant's institution：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究负责人所在单位：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Affiliation of the Leader：

The Nethersole School of Nursing, 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：

 CREC No. 2025.868

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：

香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) (香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會)

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-08 00:00:00

伦理委员会联系人：

Ms Amy Li on behalf of The Joint-NTECT CREC

Contact Name of the ethic committee：

Ms Amy Li on behalf of The Joint-NTECT CREC

伦理委员会联系地址：

8F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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 Nethersole School of Nursing, The Chinese University of Hong Kong

Primary sponsor：

Alice Ho Miu Ling Nethersole Charity Foundation

研究实施负责（组长）单位地址：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

Primary sponsor's address：

Alice Ho Miu Ling Nethersole Hospital Administration Centre, 11 Chuen On Rd, Tai Po, N.T., 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)：

香港特别行政区

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

The Nethersole School of Nursing, The Chinese University of Hong Kong

具体地址：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

Institution
hospital：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Address：

830, 8F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong SAR

经费或物资来源：

Alice Ho Miu Ling Nethersole Charity Foundation

Source(s) of funding：

Alice Ho Miu Ling Nethersole Charity Foundation

研究疾病：

Autism Spectrum Disorder  

Target disease：

Autism Spectrum Disorder

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：

横断面 

Study design：

Cross-sectional 

研究目的：

This study aims to investigate the association of mutations in MAU2 and ZFHX3, as well as other structural variants, with autism spectrum disorder (ASD) in individuals from Hong Kong. To explore distinct clinical features associated with MAU2 and ZFHX3, and other potential SVs mutations in ASD.  

Objectives of Study：

This study aims to investigate the association of mutations in MAU2 and ZFHX3, as well as other structural variants, with autism spectrum disorder (ASD) in individuals from Hong Kong. To explore distinct clinical features associated with MAU2 and ZFHX3, and other potential SVs mutations in ASD.

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

排除标准：

1 With significant injury, abnormality, or disease having effects upon the brain, extensive complications during birth or pregnancy (careful screening will be carried out for those who stayed in the hospital for more than 3 days after birth). 2 With significant nutritional and psychological deprivation*. 3 Other known genetic disorders: e.g. Down's syndrome, or Fragile X syndrome. 4 Those diagnosed with a known genetic disorder, and those with a psychiatric disorder require medication.

Exclusion criteria：

1 With significant injury, abnormality, or disease having effects upon the brain, extensive complications during birth or pregnancy (careful screening will be carried out for those who stayed in the hospital for more than 3 days after birth). 2 With significant nutritional and psychological deprivation*. 3 Other known genetic disorders: e.g. Down's syndrome, or Fragile X syndrome. 4 Those diagnosed with a known genetic disorder, and those with a psychiatric disorder require medication.

研究实施时间：

Study execute time：

从 From 2026-04-08 00:00:00至 To 2029-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2028-09-30 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 400

Group：

Observation group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特别行政区 

市(区县)：

 香港 

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 N/A 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

specific structural variations in MAU2 and ZFHX3, along with other structural variants (SVs), within the ASD patient population

指标类型：

主要指标

Outcome：

specific structural variations in MAU2 and ZFHX3, along with other structural variants (SVs), within the ASD patient population

Type：

Primary indicator

测量时间点：

After samples collection

测量方法：

DNA test (PCR and/or sequencing)

Measure time point of outcome：

After samples collection

Measure method：

DNA test (PCR and/or sequencing)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

Blood

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

in EDTA

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 1 岁 years
最大 Max age 18 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）：

None

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:

公开/Public

盲法：

None

Blinding：

None

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

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）：

None

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

None

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：

None

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

None

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：

  2026-05-30 18:44:57
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