ChiCTR2600122205 版本V1.0 版本创建时间2026/04/10 09:41:30 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：

ChiCTR2600122205 

最近更新日期：

Date of Last Refreshed on：

2026-04-10 09:41:10 

注册时间：

Date of Registration：

2026-04-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

高频超声在评估炎症性甲病患者及健康志愿者甲单元中的应用

Public title：

The Application of High-Frequency Ultrasound in Assessing Nail Units in Patients with Inflammatory Nail Disorders and Healthy Volunteers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高频超声在评估炎症性甲病患者及健康志愿者甲单元中的应用

Scientific title：

The Application of High-Frequency Ultrasound in Assessing Nail Units in Patients with Inflammatory Nail Disorders and Healthy Volunteers

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：

徐子宁 

研究负责人：

崔勇 

Applicant：

Zining Xu 

Study leader：

Yong Cui 

申请注册联系人电话：

Applicant telephone：

+86 181 8286 8989

研究负责人电话：

Study leader's telephone：

+86 157 0162 5913

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：

xuzn6323@163.com

研究负责人电子邮件：

Study leader's E-mail：

wuhucuiyong@vip.163.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：

北京市朝阳区樱花园东街2号

研究负责人通讯地址：

北京市朝阳区樱花园东街2号

Applicant address：

2 East Yinghuayuan Street, Chaoyang District, Beijing

Study leader's address：

2 East Yinghuayuan Street, Chaoyang District, Beijing

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：

中日友好医院

Applicant's institution：

China-japan Friendship Hospital

研究负责人所在单位：

中日友好医院

Affiliation of the Leader：

China-japan Friendship 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：

2026-JY-132

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：

中日友好医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of China-Japan Friendship Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-09 00:00:00

伦理委员会联系人：

闫旭

Contact Name of the ethic committee：

Xu Yan

伦理委员会联系地址：

北京市朝阳区樱花园东街2号

Contact Address of the ethic committee：

2 East Yinghuayuan Street, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 1777 6805

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：

中日友好医院

Primary sponsor：

China-japan Friendship Hospital

研究实施负责（组长）单位地址：

北京市朝阳区樱花园东街2号

Primary sponsor's address：

2 East Yinghuayuan Street, Chaoyang District, Beijing

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(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中日友好医院

具体地址：

北京市朝阳区樱花园东街2号

Institution
hospital：

China-Japan Friendship Hospital

Address：

2 East Yinghuayuan Street, Chaoyang District, Beijing

经费或物资来源：

中日友好医院

Source(s) of funding：

China-Japan Friendship Hospital

Target disease：

Inflammatory nail disease

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

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

通过影像技术系统对比炎症性甲病患者与健康人群在甲单元形态、血流及生物力学特性的差异，建立客观影像特征谱。  

Objectives of Study：

By systematically comparing the differences in the morphology, blood flow and biomechanical characteristics of the nail unit between patients with inflammatory nail disease and healthy individuals through imaging technology, an objective imaging feature spectrum was established.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 银屑病甲组（A组）：年龄 18~65 周岁（包含边界值），双手指甲银屑病甲改变患者，男女不限；通过门诊两位副高级皮肤科医师临床诊断或组织病理学上符合银屑病甲的诊断标准，研究者判断筛选前至少 6 个月内病情稳定；理解试验过程并自愿签署知情同意书。 2. 扁平苔癣甲组（B组）：年龄 18~65 周岁（包含边界值），双手指甲扁平苔癣甲改变患者，男女不限；通过门诊两位副高级皮肤科医师临床诊断或组织病理学上符合扁平苔癣甲的诊断标准，研究者判断筛选前至少 6 个月内病情稳定；理解试验过程并自愿签署知情同意书。 3. 湿疹甲组（C组）：年龄 18~65 周岁（包含边界值），双手指甲湿疹甲改变患者，男女不限；通过门诊两位副高级皮肤科医师临床诊断或组织病理学上符合湿疹甲的诊断标准，研究者判断筛选前至少 6 个月内病情稳定；理解试验过程并自愿签署知情同意书。 4. 甲癣组（D组）：年龄 18~65 周岁（包含边界值），双手指甲甲癣改变患者，男女不限；甲真菌镜检/培养为阳性且通过门诊两位副高级皮肤科医师临床诊断符合甲癣的诊断标准，研究者判断筛选前至少 6 个月内病情稳定；理解试验过程并自愿签署知情同意书。 5. 健康志愿者组（E组）：年龄、性别、职业及BMI与银屑病甲患者组相匹配的健康志愿者；通过门诊两位副高级皮肤科医师临床诊断上符合健康指甲的临床表现；理解试验过程并自愿签署知情同意书。

Inclusion criteria

1. Psoriasis Group A (Group A): Patients aged 18 to 65 years (including the boundary value), with psoriasis nail changes on both hands, regardless of gender. Based on the clinical diagnosis by two associate senior dermatologists in the outpatient department or the histopathological criteria meeting the diagnostic criteria for psoriasis, the researchers determined that the condition had been stable for at least six months before screening. Understand the trial process and voluntarily sign the informed consent form. 2. Lichenus planus Group A (Group B): Patients aged 18 to 65 years (including the boundary value) with lichenus planus nail changes on both hands, regardless of gender. Based on the clinical diagnosis by two associate senior dermatologists in the outpatient department or the histopathological criteria meeting the diagnostic criteria for lichen planus, the researchers determined that the condition had been stable for at least six months before screening. Understand the trial process and voluntarily sign the informed consent form. 3. Eczema Group A (Group C): Patients aged 18 to 65 years (including the boundary value), with eczema changes in both fingernails, regardless of gender. Based on the clinical diagnosis by two associate senior dermatologists in the outpatient department or the histopathological criteria meeting the diagnostic criteria for eczema, the researchers determined that the condition had been stable for at least six months before screening. Understand the trial process and voluntarily sign the informed consent form. 4. Onychomycosis Group (Group D): Patients aged 18 to 65 years (including the boundary value) with onychomycosis changes on both fingernails, regardless of gender. The microscopic examination/culture of onychomycosis was positive, and the clinical diagnosis by two associate senior dermatologists in the outpatient department met the diagnostic criteria for onychomycosis. The researchers judged that the condition had been stable for at least 6 months before screening. Understand the trial process and voluntarily sign the informed consent form. 5. Healthy Volunteer Group (Group E): Healthy volunteers whose age, gender, occupation and BMI were matched with those of the psoriasis patient group; The clinical manifestations of healthy nails were diagnosed by two associate senior dermatologists in the outpatient department. Understand the trial process and voluntarily sign the informed consent form.

排除标准：

1. 甲单元存在其他可能会影响超声评价的甲单元肿瘤等疾病； 2. 指甲外伤、指甲磨削及美甲佩戴者； 3. 其他研究者认为不适宜入选本研究的情况。

Exclusion criteria：

1. There are other diseases in Unit A that may affect ultrasound evaluation, such as Unit A tumors; 2. People with nail trauma, nail grinding or nail art wear; 3. Situations where other researchers consider it inappropriate to be included in this study.

研究实施时间：

Study execute time：

从 From 2026-04-12 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-12 00:00:00 至 To 2027-06-30 00:00:00  

诊断试验：

Diagnostic Tests：

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）：

甲真菌病：真菌镜检与培养/组织病理学检查(PAS染色) 甲扁平苔藓：临床表现结合皮肤病史 甲湿疹：临床表现 银屑病甲：临床表现(结合病史)

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):

Onychomycosis: Microscopic examination and culture of fungi/histopathological examination (PAS staining) Lichen planus: Clinical manifestations combined with a history of dermatology Nail Eczema: Clinical manifestations Psoriasis A: Clinical manifestations (combined with medical history)

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）：

不同甲病的高频超声影像学表现

Index test:

High-frequency ultrasound imaging manifestations of different nail diseases

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）

炎症性甲病患者

例数:

Sample size:

110

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):

Patients with inflammatory nail disease

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）：

脆甲：常表现为 1.甲板变薄:指甲厚度显著减少，像纸一样薄，透过指甲可以看到下方的甲床颜色(显得发红或苍白)。 2.表面粗糙:失去健康甲的光泽和光滑感，变得黯淡、粗糙、有砂纸感。 3.游离缘破碎:指甲尖端无法保持平整的弧线，总是呈现锯齿状或粉碎状。 4.无炎症:这是脆甲与甲真菌病、银屑病甲的重要鉴别点。脆甲通常不伴有甲周红肿、疼痛、流脓，也没有甲下碎屑堆积或甲板颜色异常(如黄、绿、黑)，因此极易与健康组混淆。

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:

Brittle nail: It is often manifested as follows: 1. Thinning of the nail plate: The thickness of the nail is significantly reduced, as thin as paper, and the color of the nail bed beneath can be seen through the nail (appearing red or pale). 2. Rough surface: It loses the luster and smoothness of a healthy nail, becoming dull, rough and having a sandpaper-like feel. 3. Broken free edge: The tip of the nail cannot maintain a smooth arc and always appears serrated or crushed. 4. Absence of inflammation: This is an important differentiating point between brittle nails and onychomycosis and psoriatic nails. Brittle nails usually do not have redness, swelling, pain or pus discharge around the nail, nor do they have debris accumulation under the nail or abnormal nail plate color (such as yellow, green or black), and thus are very easy to be confused with the healthy group.

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中日友好医院 

单位级别：

三甲 

Institution
hospital：

China-japan Friendship Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

甲床厚度

指标类型：

主要指标

Outcome：

Deck thickness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

甲板厚度

指标类型：

主要指标

Outcome：

Deck thickness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

甲根长度

指标类型：

次要指标

Outcome：

Length of the nail root

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

准确度

指标类型：

主要指标

Outcome：

Accuracy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

灵敏度

指标类型：

次要指标

Outcome：

Sensitivity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

特异度

指标类型：

次要指标

Outcome：

Specificity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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)：

NA

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

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）：

可联系试验联系人获取

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

It can be obtained by contacting the test contact person

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：

临床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）。临床患者信息以病例记录表的方式采集获取，患者图像信息以病例记录表和电子录入的方式采集管理。

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

Clinical Data collection and management consist of two parts: one is the Case Record Form (CRF), and the other is the Electronic Data Capture and management system (EDC). Clinical patient information is collected and obtained in the form of case record forms, and patient image information is collected and managed through case record forms and electronic input.

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：

  2026-04-10 09:41:10