中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600125938
最近更新日期： Date of Last Refreshed on：	2026-06-01 17:29:56
注册时间： Date of Registration：	2026-06-01 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于多模态数据的食管鳞癌淋巴结转移预测模型构建研究
Public title：	Research on constructing a prediction model for lymph node metastasis in esophageal squamous cell carcinoma based on multimodal data
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于多模态数据的食管鳞癌淋巴结转移预测模型构建研究
Scientific title：	Research on constructing a prediction model for lymph node metastasis in esophageal squamous cell carcinoma based on multimodal data
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：	周金松	研究负责人：	周金松
Applicant：	Zhou Jinsong	Study leader：	Zhou Jinsong
申请注册联系人电话： Applicant telephone：	+86 591 88618563	研究负责人电话： Study leader's telephone：	+86 591 88618562
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：	zhoujinsongyx@163.com	研究负责人电子邮件： Study leader's E-mail：	zhoujinsongyx@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：	中国福建省福州市仓山区金榕南路516号	研究负责人通讯地址：	中国福建省福州市鼓楼区东街134号
Applicant address：	516 Jinrong South Road, Cangshan District, Fuzhou, Fujian, China	Study leader's address：	134 East Street, Gulou District, Fuzhou, Fujian, 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：	福州大学附属省立医院
Applicant's institution：	Fuzhou University Affiliated Provincial Hospital
研究负责人所在单位：	福州大学附属省立医院
Affiliation of the Leader：	Fuzhou University Affiliated Provincial Hospital

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：	伦审科研第(K2026-05-064)号	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：	福州大学附属省立医院伦理委员会
Name of the ethic committee：	Ethics Committee of Fuzhou University Affiliated Provincial Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-26 00:00:00
伦理委员会联系人：	练发杨
Contact Name of the ethic committee：	Lian Fayang
伦理委员会联系地址：	中国福建省福州市鼓楼区东街134号
Contact Address of the ethic committee：	134 East Street, Gulou District, Fuzhou, Fujian, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 591 88216023	伦理委员会联系人邮箱： Contact email of the ethic committee：	fjslec@163.com

研究实施负责（组长）单位：

福州大学附属省立医院

Primary sponsor：

Fuzhou University Affiliated Provincial Hospital

研究实施负责（组长）单位地址：

中国福建省福州市鼓楼区东街134号

Primary sponsor's address：

134 East Street, Gulou District, Fuzhou, Fujian, 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)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福州大学附属省立医院	具体地址：	中国福建省福州市鼓楼区东街134号
Institution hospital：	Fuzhou University Affiliated Provincial Hospital	Address：	134 East Street, Gulou District, Fuzhou, Fujian, China

经费或物资来源：

福建省自然科学基金项目

Source(s) of funding：

Fujian Provincial Natural Science Foundation

研究疾病：

食管鳞癌淋巴结转移

Target disease：

Lymph Node Metastasis of Esophageal Squamous Cell Carcinoma

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：

队列研究

Study design：

Cohort study

研究目的：

本研究拟通过整合临床信息、影像组学、外泌体蛋白组学与微生物组学特征等多模态数据，深入挖掘影响淋巴结转移的关键因素，并应用多模态数据融合技术构建可解释的食管鳞状细胞癌淋巴结转移预测模型，从而为临床诊疗提供决策支持，帮助制定个性化治疗方案。

Objectives of Study：

The present study aims to comprehensively explore the key factors influencing lymph node metastasis (LNM) by integrating multimodal data including clinical information, radiomics, exosomal proteomics, and microbiomics features. Furthermore, we will apply multimodal data fusion technology to construct an interpretable predictive model for LNM in esophageal squamous cell carcinoma (ESCC), thereby providing decision support for clinical diagnosis and treatment, and facilitating the formulation of personalized treatment regimens for patients.

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.临床病理资料和组织标本不完整者；
2.继发性食管肿瘤和食管癌复发者；
3.近1个月内接受过对试验结果有影响的相关药物治疗者，如口服、肌内注射和静脉输注的抗菌药物，各种益生菌等微生态制剂以及其他影响菌群的药物；
4.伴有其他严重内科疾病者；
5.病情危重不能清晰回答问题者；

Exclusion criteria：

1.Those with incomplete clinical pathological data and tissue specimens;
2.Patients with secondary esophageal tumors and recurrent esophageal cancer;
3.Individuals who have received relevant drug treatments within the past month that may have affected the trial results, such as oral, intramuscular, and intravenous antibiotics, various probiotics and other microecological agents, as well as other drugs that affect the microbiota;
4.Individuals with other severe internal diseases;
5.Individuals who are critically ill and unable to answer questions clearly;

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2029-04-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2029-04-30 00:00:00

干预措施：

Interventions：

组别：	食管鳞癌患者	样本量：	250
Group：	Esophageal squamous cell carcinoma patients	Sample size：	250
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)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福州大学附属省立医院	单位级别：	三级甲等
Institution hospital：	Fuzhou University Affiliated Provincial Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	外泌体蛋白检测	指标类型：	主要指标
Outcome：	Exosomal Protein Detection	Type：	Primary indicator
测量时间点：	收集血液样本后	测量方法：	ELISA
Measure time point of outcome：	After the collection of blood samples	Measure method：	ELISA

指标中文名：	菌群特征	指标类型：	主要指标
Outcome：	Microbiota Features	Type：	Primary indicator
测量时间点：	收集组织样本后	测量方法：	16S rRNA测序
Measure time point of outcome：	After collecting tissue samples	Measure method：	16S rRNA sequencing

指标中文名：	人口学特征	指标类型：	主要指标
Outcome：	Demographic characteristics	Type：	Primary indicator
测量时间点：	入组时	测量方法：	问卷调查
Measure time point of outcome：	At enrollment	Measure method：	Questionnaire survey

指标中文名：	模型性能	指标类型：	主要指标
Outcome：	Model performance	Type：	Primary indicator
测量时间点：		测量方法：	ROC 曲线、precision-recall 曲线、校准曲线、F1 score、敏感性、特异性、 PPV、NPV 和 Brier 评分等评估方法
Measure time point of outcome：		Measure method：	Evaluation methods such as ROC curve, precision-recall curve, calibration curve, F1 score, sensitivity, specificity, PPV, NPV and Brier score

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	食管鳞癌组织	组织：
Sample Name：	Esophageal squamous cell carcinoma 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：	血液	组织：
Sample Name：	Blood	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	NA	岁 years
最大 Max age	NA	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)：

None

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：	无
Blinding：	None

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）：	本研究全部原始调研数据、实验检测数据及统计分析数据均完整归档留存。相关科研人员若因学术研究、成果复核等合理用途需要调取原始数据，可通过通讯作者预留邮箱提交书面申请，注明数据使用目的、研究方向与使用范围，审核通过后将依规提供对应原始数据资料。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	All original survey data, experimental test data and statistical analysis data of this study are fully archived and preserved. Relevant researchers who need to access the raw data for legitimate purposes such as academic research and result verification may submit a written application via the corresponding author's reserved email. Applicants shall specify the data usage purpose, research orientation and scope of use. Corresponding original data will be provided in accordance with regulations upon approval.
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：	本研究严格规范各类研究数据的收集、核验与归档管理流程，主要涵盖临床随访信息、影像数据与样本检测数据三大模块，全方位保障研究数据的真实性、完整性、准确性与规范性。临床与随访信息收集方面，研究采用统一编制的结构式调查问卷开展数据采集工作，正式调查前对所有调查员开展标准化统一培训，规范调查流程与问询标准，最大限度规避人为误差，保障调研资料的完整度与精准度。研究以面对面问询结合体格检查的方式，对签署知情同意的研究对象开展系统调查，收集内容涵盖一般人口学特征、生活与环境暴露因素、食物频率情况及EORTC生命质量量表评分等相关信息；同时依托医院正规病历系统，整理记录研究对象的肿瘤部位、组织学类型、TNM分期、分化程度、血液检验结果及临床治疗方案等核心临床资料。随访工作采用门诊复查、科室常规随访与电话随访相结合的多元化方式，自患者术后首日启动随访，每3个月开展一次定期随访，通过EORTC QLQ-C30、QLQ-OES18量表持续评估患者生命质量，同步记录患者生存状态、肿瘤复发及转移情况，严格把控随访质量，有效降低研究失访率。所有问卷及随访获取的信息均由专职数据录入人员及时核对、补充完善与纠错修正，随后采用EpiData 3.1软件实施数据双录入，通过逻辑纠错、一致性检验等多重质控手段，彻底剔除错误、缺失及矛盾数据，确保临床随访数据精准可靠。 CT影像数据采集与管理严格遵循标准化操作规范，统一采用Toshiba Aquilion One 320排CT机完成胸部螺旋扫描，检查时指导患者取仰卧位并配合屏气，扫描范围覆盖胸廓入口至肺底区域。固定核心扫描参数：管电压120 KV，依托自动管电流调节技术设置100~300 mA的管电流自适应调节范围，螺距0.87，转速0.50 s/圈，准直器宽度160×0.5 mm，扫描矩阵512×512，图像层厚与层间距均设置为0.5 mm。患者经常规CT平扫后，采用浓度为300 mgI/ml的非离子型对比剂碘帕醇开展增强扫描，对比剂总剂量依据患者体重核定为1.5 ml/kg，总量控制在60~80 ml，通过高压注射器以3.0~3.5 ml/s的流率静脉注射，分别延迟20~30 s、60~70 s完成动脉期与静脉期扫描。所有采集完成的患者影像资料均进行系统化整理归档，以患者住院号为统一命名规则建立专属病例文件夹，所有影像数据统一保存为医学标准DICOM格式，实现影像数据的规范化存储、统一管理与可追溯核查，为后续影像分析、数据复核及相关研究工作开展提供标准化、高质量的数据支撑。样本检测数据方面，严格遵循无菌、标准化生物样本采集与检测流程开展数据收集工作。研究收集食管鳞癌患者的手术肿瘤组织及对应癌旁正常组织、外周血样本，采集完成后即刻进行标准化处理，通过低温离心、分装标记后置于超低温冰箱冷冻保存，全程规范样本储存条件，避免样本降解、污染影响检测结果。所有样本统一采用专属编码规则编号，与患者住院号一一对应，精准记录样本采集时间、样本类型、处理方式、储存位置等基础信息，建立完整的样本溯源台账。后续严格按照实验操作规程开展各类指标检测，实验所用试剂、仪器均经过质量校验，检测过程全程做好数据原始记录，完整留存实验读数、运算结果、重复检测数据等全部原始资料。检测完成后，对所有样本检测数据进行逐一复核，剔除因样本不合格、实验操作误差、仪器异常导致的无效数据，同步完成数据分类整理与标准化归档，保障样本检测数据的真实性、重复性与可靠性，为后续实验数据分析提供严谨、规范的数据基础。本研究全程严格遵循医学科研伦理要求与患者隐私保护相关规定，建立完善的患者信息隐私管理制度。所有收集的人口学资料、临床病历信息、随访数据、CT影像资料及样本检测数据均为研究专用，全程实行脱敏处理，隐匿患者姓名、身份证号、联系方式、家庭住址等一切可识别个人身份的敏感信息，仅保留研究所需的编码化病例信息用于数据分析。所有研究数据由专人统一保管，存储于加密电脑及专属文件夹，设置独立访问权限与登录密码，严禁未经授权的查阅、拷贝与外传。研究过程中及成果发表时，均不泄露患者个人隐私信息，所有数据仅用于本研究学术分析使用，不用于其他商业及非研究用途，有效保障所有研究对象的个人隐私与信息安全。本研究全程严格遵循医学科研伦理要求与患者隐私保护相关规定，建立完善的患者信息隐私管理制度。所有收集的人口学资料、临床病历信息、随访数据及CT影像资料均为研究专用，全程实行脱敏处理，隐匿患者姓名、身份证号、联系方式、家庭住址等一切可识别个人身份的敏感信息，仅保留研究所需的编码化病例信息用于数据分析。所有研究数据由专人统一保管，存储于加密电脑及专属文件夹，设置独立访问权限与登录密码，严禁未经授权的查阅、拷贝与外传。研究过程中及成果发表时，均不泄露患者个人隐私信息，所有数据仅用于本研究学术分析使用，不用于其他商业及非研究用途，有效保障所有研究对象的个人隐私与信息安全。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This study strictly standardized the procedures for the collection, verification, and archiving of all research data, mainly including three modules: clinical follow-up information, imaging data, and sample detection data, to comprehensively ensure the authenticity, completeness, accuracy, and standardization of research data. In terms of clinical and follow-up information collection, a uniformly designed structured questionnaire was adopted for data acquisition. Before the formal investigation, all investigators received standardized unified training to standardize the investigation procedures and inquiry criteria, minimize human errors, and guarantee the completeness and accuracy of research data. Systematic investigations and physical examinations were performed on subjects who signed informed consent through face-to-face interviews. The collected information included general demographic characteristics, living and environmental exposure factors, food frequency, and EORTC quality of life scale scores. Meanwhile, based on hospital medical records, core clinical data of subjects were recorded, including tumor location, histological type, TNM stage, differentiation degree, blood test results, and treatment regimens. Regular follow-up was initiated on the first day after surgery and conducted every 3 months through a combination of outpatient reexamination, ward follow-up, and telephone interview. The EORTC QLQ-C30 and QLQ-OES18 scales were applied to continuously evaluate patients’ quality of life, and patients’ survival status, tumor recurrence, and metastasis were synchronously recorded to strictly control follow-up quality and reduce the loss to follow-up rate. All questionnaire and follow-up data were timely checked, supplemented, and corrected by professional data entry personnel. EpiData 3.1 software was used for double data entry. Multiple quality control measures including logical error correction and consistency test were performed to eliminate erroneous, missing, and contradictory data, ensuring the accuracy and reliability of clinical follow-up data.The collection and management of CT imaging data were conducted in strict accordance with standardized operating protocols. All chest spiral scans were performed using a Toshiba Aquilion One 320-row CT scanner. Patients were placed in the supine position and instructed to hold their breath, with the scanning range from the thoracic inlet to the lung base. The fixed scanning parameters were set as follows: tube voltage of 120 kV, automatic tube current modulation ranging from 100 to 300 mA, pitch of 0.87, rotation speed of 0.50 s per cycle, collimation width of 160×0.5 mm, and a matrix of 512×512. The slice thickness and interval were both 0.5 mm. After routine plain CT scanning, enhanced scanning was performed using the non-ionic contrast agent Iopamidol (300 mgI/mL). The total contrast agent dosage was 60–80 mL (1.5 mL/kg according to body weight), which was intravenously injected via a high-pressure syringe at a flow rate of 3.0–3.5 mL/s. Arterial phase scanning was performed at a delay of 20–30 s, and venous phase scanning at 60–70 s. All acquired imaging data were systematically sorted and archived. A dedicated patient folder was established and uniformly named according to the inpatient admission number, and all imaging data were stored in standard Digital Imaging and Communications in Medicine (DICOM) format, realizing standardized storage, unified management, and traceability of imaging data to provide high-quality data support for subsequent imaging analysis and data verification.For sample detection data, the collection was carried out in strict accordance with aseptic and standardized biological sample collection and testing protocols. Tumor tissues, paired adjacent normal tissues, and peripheral blood samples were collected from patients with esophageal squamous cell carcinoma. Immediately after collection, all samples were processed through low-temperature centrifugation, aliquoting, and labeling, and then stored in an ultra-low temperature refrigerator to avoid sample degradation and contamination that might affect test results. All samples were numbered with a unified exclusive coding system corresponding to the patient’s admission number one by one. Detailed information including sample collection time, sample type, processing method, and storage location was recorded to establish a complete sample traceability ledger. All indicator detections were performed in strict accordance with standard experimental operating procedures. All reagents and instruments were fully calibrated before use. Original experimental records including instrument readings, calculation results, and repeated test data were completely retained throughout the detection process. After detection, all data were reviewed one by one, and invalid data caused by unqualified samples, operational errors, or instrument abnormalities were excluded. All valid data were classified and archived uniformly to ensure the authenticity, repeatability, and reliability of sample detection data and provide a rigorous and standardized data foundation for subsequent statistical analysis.This study fully complied with medical research ethics principles and patient privacy protection regulations, with a complete privacy management system established for research information. All collected demographic data, clinical medical records, follow-up information, CT imaging data, and sample detection data were exclusively used for this research. All personal sensitive information that could identify individual subjects, including name, ID number, contact information, and residential address, was desensitized, and only coded case information required for statistical analysis was retained. All research data were uniformly managed by designated researchers and stored in encrypted computers with exclusive folders equipped with independent access permissions and login passwords. Unauthorized access, copying, and external transmission of data were strictly prohibited. No patient privacy information was disclosed during the research process or result publication. All data were only used for academic analysis of the present study and were not applied for commercial or non-research purposes, which effectively guaranteed the personal privacy and information security of all research subjects.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-01 17:29:48