ChiCTR2500114784 版本V1.0 版本创建时间2025/12/17 16:27:47 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：

ChiCTR2500114784 

最近更新日期：

Date of Last Refreshed on：

2025-12-17 16:27:28 

注册时间：

Date of Registration：

2025-12-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于C?TIRADS的“双轨干预”在提高甲状腺结节超声诊断效能的前瞻性随机对照研究

Public title：

A Prospective, Randomized, Controlled Trial of a Dual-Track Intervention Based on the Chinese Thyroid Imaging Reporting and Data System (C-TIRADS) to Improve Ultrasound Diagnostic Performance for Thyroid Nodules

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于C?TIRADS的“双轨干预”在提高甲状腺结节超声诊断效能的前瞻性随机对照研究

Scientific title：

A Prospective, Randomized, Controlled Trial of a Dual-Track Intervention Based on the Chinese Thyroid Imaging Reporting and Data System (C-TIRADS) to Improve Ultrasound Diagnostic Performance for Thyroid Nodules

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：

宋恒涛 

研究负责人：

宋恒涛 

Applicant：

Hengtao Song 

Study leader：

Hengtao Song 

申请注册联系人电话：

Applicant telephone：

+86 915 818 3624

研究负责人电话：

Study leader's telephone：

+86 915 818 3624

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：

2103847089@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2103847089@qq.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：

陕西省安康市汉滨区巴山东路47号

研究负责人通讯地址：

陕西省安康市汉滨区巴山东路47号

Applicant address：

No. 47, Bashan East Road, Hanbin District, Ankang City, Shaanxi Province, China

Study leader's address：

No. 47, Bashan East Road, Hanbin District, Ankang City, Shaanxi Province, 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：

安康市中医医院

Applicant's institution：

Ankang Hospital of Traditional Chinese Medicine

研究负责人所在单位：

安康市中医医院

Affiliation of the Leader：

Ankang Hospital of Traditional Chinese Medicine

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：

2025AKZYLL-KY037-02

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：

安康市中医医院涉及人的生物医学研究伦理分会

Name of the ethic committee：

IRB of Ankang Hospital of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-09 00:00:00

伦理委员会联系人：

李天怡

Contact Name of the ethic committee：

Li TianYi

伦理委员会联系地址：

陕西省安康市汉滨区巴山东路47号

Contact Address of the ethic committee：

No. 47, Bashan East Road, Hanbin District, Ankang City, Shaanxi Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 915 8183569

伦理委员会联系人邮箱：

Contact email of the ethic committee：

suchacuteguy@163.com

研究实施负责（组长）单位：

安康市中医医院

Primary sponsor：

Ankang Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

陕西省安康市汉滨区巴山东路47号

Primary sponsor's address：

No. 47, Bashan East Road, Hanbin District, Ankang City, Shaanxi Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

Country：

China

Province：

Shaanxi

City：

单位(医院)：

安康市中医医院

具体地址：

陕西省安康市汉滨区巴山东路47号

Institution
hospital：

Ankang Hospital of Traditional Chinese Medicine

Address：

No. 47, Bashan East Road, Hanbin District, Ankang City, Shaanxi Province, China

经费或物资来源：

2025年安康市中医医院科技发展孵化基金项目

Source(s) of funding：

2025 Science and Technology Development Incubation Fund Project of Ankang Hospital of Traditional Ch

Target disease：

Thyroid Nodules

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

预期将我院探头超速事件率尽可能降低，从而降低关键解剖标志（如甲状腺峡部、颈动脉鞘）的显影位置偏差所致漏诊、误诊；以及通过构建设备-操作双轨干预框架，同步制定适合安康人群的超声设备增益补偿表，以期制定适合地方特色的《甲状腺结节超声操作手册》的推广应用，推动本区域检验检查结果互认率提升，为国家分级诊疗政策在资源受限地区的落地提供可复制的技术范式。  

Objectives of Study：

To develop a dynamic gain-compensation protocol that minimizes inter-device fluctuations in capturing micro-calcification texture features; to reduce operator variability by adding an industrial-grade accelerometer to the ultrasound probe, thereby lowering probe over-speed events and associated diagnostic errors involving key anatomical landmarks such as the thyroid isthmus and carotid sheath; and to build an equipment-operation dual-track intervention framework that generates a gain-compensation chart tailored to the Ankang population, formulates a locally adapted “Ultrasound Operating Manual for Thyroid Nodules,” improves mutual recognition of imaging results within the region, and offers a reproducible technical paradigm for implementing China’s tiered healthcare policy in resource-constrained settings.

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.年龄18–75岁；
2.经彩色多普勒超声发现甲状腺结节并完成TI-RADS分级；
3.单发或多发均可，但最大可疑结节直径≥0.4 cm 且具备至少一种高危超声表现；
4.拟行常规检查并可配合“双轨干预”流程及追踪12个月随访者；
5.签署书面知情同意书。

Inclusion criteria

1. Age 18–75 years; 2. Thyroid nodules detected by color Doppler ultrasound and classified with TI-RADS; 3. Either solitary or multiple nodules are acceptable, but the largest suspicious nodule must be >=0.4 cm in diameter and exhibit at least one high-risk ultrasound feature; 4. Willing and able to undergo routine examinations, comply with the "dual-track intervention" protocol, and complete 12 months of follow-up; 5. Written informed consent obtained.

排除标准：

1.有颈部手术史、放射治疗史致解剖结构明显改变者；
2.妊娠期及哺乳期妇女；
3.探头接触禁忌如开放创口感染者；
4.超声明显图像质量缺陷无法纠正者；
5.合并其他活动期恶性肿瘤。

Exclusion criteria：

1. History of neck surgery or radiotherapy that has led to significant anatomical alteration; 2. Pregnant or lactating women; 3. Contraindications to probe contact, such as open wounds or infections; 4. Ultrasound images with uncorrectable, significant quality defects; 5. Presence of other active malignant tumors.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

84

Group：

control group

Sample size：

干预措施：

常规操作

干预措施代码：

Intervention：

routine operation

Intervention code：

组别：

干预组

样本量：

84

Group：

intervention group

Sample size：

干预措施：

双轨干预

干预措施代码：

Intervention：

dual-track intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

  

Country：

China 

Province：

Shaanxi 

City：

 

单位(医院)：

安康市中医医院 

单位级别：

三级甲等 

Institution
hospital：

AnKang Hospital of traditional chinese medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

关键切面获取完整率提升幅度

指标类型：

主要指标

Outcome：

Magnitude of improvement in the completeness rate of key-plane acquisition.

Type：

Primary indicator

测量时间点：

检查结束即刻

测量方法：

四个标准切面中解剖标志覆盖≥90%的比例，由两名盲法质控医师评分并用κ系数验证一致性(Kappa≥0.75视为高度一致)。

Measure time point of outcome：

immediately upon completion of the examination

Measure method：

Proportion of the four standard planes in which ≥ 90 % of anatomical landmarks are covered, assessed by two blinded quality-control physicians; inter-rater agreement will be verified using the κ coefficient (Kappa ≥ 0.75 is regarded as high concordance).

指标中文名：

诊断准确性

指标类型：

主要指标

Outcome：

Diagnostic accuracy

Type：

Primary indicator

测量时间点：

手术或穿刺结束后1周

测量方法：

基于病理学结果或随访结局计算敏感度(SENS)、特异度(SPEC)、阳性预测值(PPV)、阴性预测值(NPV)及ROC曲线下面积(AUC)，敏感度=真阳性/ (真阳性+假阴性)，特异度=真阴性/ (真阴性+假阳性)，AUC通过ROC分析获得

Measure time point of outcome：

One week after completion of surgery or puncture.

Measure method：

Based on pathological findings or follow-up outcomes, sensitivity (SENS), specificity (SPEC), positive predictive value (PPV), negative predictive value (NPV), and the area under the receiver-operating-characteristic curve (AUC) will be calculated. Sensitivity = true positives / (true positives + false negatives); specificity = true negatives / (true negatives + false positives); the AUC will be obtained through ROC analysis

指标中文名：

探头超速事件发生率下降幅度

指标类型：

主要指标

Outcome：

magnitude of reduction in probe overspeed event incidence

Type：

Primary indicator

测量时间点：

检查结束即刻

测量方法：

每例扫描中探头平均速度>3.0?cm/s触发报警的次数÷总扫描切面次数×100%。数据来源：加速度传感器自动记录日志

Measure time point of outcome：

immediately upon completion of the examination

Measure method：

The proportion of alarms triggered per examination when the probe’s mean scanning speed exceeds 3.0 cm/s, calculated as (number of alarms triggered ÷ total number of scanned planes) × 100%. The data source is the automatically recorded log from the accelerometer.

指标中文名：

血流分级分布变化

指标类型：

次要指标

Outcome：

Alterations in Blood Flow Grade Distribution

Type：

Secondary indicator

测量时间点：

初次检查结束后6月

测量方法：

在甲状腺结节的超声检查中，采用彩色多普勒血流成像（Color Doppler Flow Imaging, CDFI）评估结节内部及周边血流信号，根据血流分级标准（如 Adler 分级法）进行分级： 0级：无血流信号 Ⅰ级：少量点状或短线状血流信号 Ⅱ级：中等数量血流信号，呈点状、短线状或少量长线状 Ⅲ级：丰富血流信号，呈长线状或网状分布 在初次检查及随访（如 6 个月后）分别记录各级血流分布比例

Measure time point of outcome：

At 6 months after completion of the initial examination

Measure method：

Blood flow within and around the thyroid nodule will be assessed using Color Doppler Flow Imaging (CDFI). The grading will follow the Adler classification: Grade 0: No detectable blood flow signal Grade I: A few punctate or short linear blood flow signals Grade II: Moderate number of blood flow signals, punctate, short linear, or a few long linear signals Grade III: Abundant blood flow signals, long linear or network-like distribution The proportion of nodules in each grade will be recorded at

指标中文名：

诊断措施

指标类型：

主要指标

Outcome：

Diagnostic Methods

Type：

Primary indicator

测量时间点：

手术或穿刺结束后1周

测量方法：

敏感度（SENS） = 真阳性 / (真阳性 + 假阴性)；特异度（SPEC） = 真阴性 / (真阴性 + 假阳性)；阳性预测值（PPV）、阴性预测值（NPV）；ROC 曲线下面积（AUC） 通过 ROC 分析获得。

Measure time point of outcome：

One week after completion of surgery or puncture.

Measure method：

Sensitivity (SENS) = True Positive / (True Positive + False Negative) Specificity (SPEC) = True Negative / (True Negative + False Positive) Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Area Under the ROC Curve (AUC) obtained through ROC analysis.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

甲状腺

组织：

Sample Name：

thyroid tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

甲状腺组织

组织：

Sample Name：

thyroid tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 18 岁 years
最大 Max age 75 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）：

所有符合纳入标准并签署知情同意书的受试者，在来院检查当天，在未知其C-TIRADS 分类结果的情况下进行随机分配；随机分组比例为 1:1，按受试者当日登记顺序依次编号，奇数号分配至对照组（执行常规操作），偶数号分配至干预组（执行“双轨干预”）；确保两组患者来源、时间框架及基线条件可比。分配过程由与影像采集无关的指定研究助理执行，并在患者进入超声检查室前完成，以避免操作者提前预测和人为选择。

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

All subjects who meet the inclusion criteria and have provided written informed consent will be randomly assigned on the day of their hospital visit before their C-TIRADS classification is revealed. Randomization will follow a 1:1 allocation ratio based on the sequential registration number of that day: odd numbers will be assigned to the control group (standard procedure), and even numbers to the intervention group (dual-track intervention). This method guarantees comparability between groups in terms of patient source, time frame, and baseline characteristics. The assignment will be carried out by a designated research assistant who is not involved in image acquisition and will be completed before the patient enters the ultrasound examination room, thereby preventing the operator from anticipating the assignment and avoiding selection bias.

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：

双盲，研究对象（患者）无需知晓自己归属干预组还是对照组；执行结果评价/图像判读的质控医师也不知晓该病例来自哪一分组，只依据影像资料和质控标准评分，这样可以避免因知晓分组而产生倾向性判断。

Blinding：

Double blind, The research subjects (patients) do not need to know whether they belong to the intervention group or the control group; The quality control physician performing the result evaluation/image interpretation also does not know which group the case comes from, and only scores based on imaging data and quality control standards, which can avoid biased judgments due to knowing the group.

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）：

2027-07-01；邮箱；https://accounts.google.com/b/0/AddMailService

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

2027-07-01；google；https://accounts.google.com/b/0/AddMailService

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：

本研究的数据管理将严格遵循临床科研数据质量控制与隐私保护要求，所有受试者在纳入时均填写统一的《筛选与入选表》，明确记录纳排标准判定依据及签署的知情同意书；检查过程中采集的原始彩超图像（包括四个关键切面静态图、Cine-loop视频）及加速度传感器限速日志均由操作者当日上传至院内加密服务器，并由两名经培训的数据员分别进行电子病例报告表（CRF）双人独立录入，比对差异后第三方复核确认一致性；每位受试者分配唯一研究编码，与影像文件、传感器日志及病理/随访结果关联，去除姓名、身份证号等敏感信息，仅保留必要医学变量，编码对照表加密单独存放，由项目负责人和指定数据管理员掌握；所有原始纸质资料按编号归档于上锁档案柜保存，电子数据每日自动备份至安全服务器并设定分级访问权限，操作者仅能访问本人负责病例去标识化信息，质控专家可查阅全组脱敏影像用于评分分析，统计人员仅获取分析所需脱敏数据集；数据库开启操作日志功能，全程记录新增、修改、删除行为以便审计追溯，并定期抽样回查原始影像与分析结果一致性，对发现问题的及时整改形成书面记录；所有原始资料、中间处理文件和分析输出至少保存5年，以确保研究数据真实可靠、安全可控且全程可溯源。

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

Data management in this study will strictly adhere to clinical research requirements for data quality control and privacy protection. Upon enrollment, every participant will complete a standardized “Screening and Enrollment Form,” which documents the rationale for inclusion or exclusion and the signed informed consent. All raw colour-Doppler ultrasound data acquired during the examination—including static images of the four key planes and Cine-loop videos—together with speed-limiting logs from the accelerometer, will be uploaded by the operator on the same day to an encrypted in-hospital server.Two trained data clerks will independently perform double data entry of the electronic Case Report Forms (CRFs); discrepancies will be compared, and a third party will review and confirm concordance. Each participant will be assigned a unique study code that links imaging files, sensor logs, and pathological or follow-up results. Personal identifiers (e.g., name, ID number) will be removed, and only essential medical variables retained. The code-linkage table will be encrypted, stored separately, and accessible solely to the principal investigator and the designated data manager.All original paper documents will be archived numerically in locked filing cabinets. Electronic data will be backed up automatically each day to a secure server, with tiered access control: operators may access only de-identified information for their own cases; quality-control experts may review the fully de-identified image set for scoring; statisticians will receive only the de-identified dataset necessary for analysis. The database will maintain an audit trail that logs every addition, modification, and deletion for traceability. Regular random checks will compare raw images with analytical outputs; any issues identified will be rectified promptly, with written documentation.All original materials, intermediate processing files, and analytical outputs will be retained for a minimum of five years to ensure that the study data are authentic, reliable, secure, controllable, and fully traceable.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-17 16:27:28