ChiCTR2500107504 版本V1.0 版本创建时间2025/08/13 08:57:29 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：

ChiCTR2500107504 

最近更新日期：

Date of Last Refreshed on：

2025-08-13 08:57:01 

注册时间：

Date of Registration：

2025-08-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于机器学习的血浆代谢组学方法筛选泌尿生殖系统肿瘤生物标志物的病例对照研究

Public title：

A case-control study on screening biomarkers of Genitourinary tumors based on machine learning and plasma metabolomics methods

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于机器学习的血浆代谢组学方法筛选泌尿生殖系统肿瘤生物标志物的病例对照研究

Scientific title：

A case-control study on screening biomarkers of Genitourinary tumors based on machine learning and plasma metabolomics methods

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：

汪科杉 

研究负责人：

章小平 

Applicant：

Keshan Wang 

Study leader：

Xiaoping Zhang 

申请注册联系人电话：

Applicant telephone：

+86 18071749296

研究负责人电话：

Study leader's telephone：

+86 27 85726685

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：

wks4869@hust.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

xzhang@hust.edu.cn

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：

湖北省武汉市解放大道1277号

研究负责人通讯地址：

湖北省武汉市江汉区解放大道1277号

Applicant address：

No. 1277, Jiefang Avenue, Wuhan City, Hubei Province

Study leader's address：

NO.1277 Jiefang Avenue, Wuhan, Hubei Province

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：

华中医科大学同济医学院附属协和医院

Applicant's institution：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究负责人所在单位：

华中科技大学同济医学院附属协和医院

Affiliation of the Leader：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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：

[2025]伦审字（0625）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：

华中科技大学同济医学院附属协和医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Union Hospital of Tongji Medical College Huazhong University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-30 00:00:00

伦理委员会联系人：

褚圆圆

Contact Name of the ethic committee：

Chu YuanYuan

伦理委员会联系地址：

湖北省武汉市江汉区解放大道1277号

Contact Address of the ethic committee：

NO.1277 Jiefang Avenue, Wuhan, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 27 85726375

伦理委员会联系人邮箱：

Contact email of the ethic committee：

994877373@qq.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市江汉区解放大道1277号

Primary sponsor's address：

NO.1277 Jiefang Avenue, Wuhan, Hubei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

华中科技大学同济医学院附属协和医院

具体地址：

湖北省武汉市江汉区解放大道1277号

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

NO.1277 Jiefang Avenue, Wuhan, Hubei Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funding

Target disease：

Bladder cancer；Renal cell carcinoma；Prostate cancer

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

1) 识别特异性生物标志物 —— 系统性地分析泌尿生殖系统肿瘤患者与健康对照的血浆代谢组，识别出与肿瘤发生密切相关的差异代谢物，这些代谢物有望作为潜在的生物标志物用于临床实践。 2) 构建预测模型 —— 应用机器学习方法根据已知病例和对照的血浆代谢数据训练和验证分类模型，以期达到高效、准确地识别各类泌尿生殖系统肿瘤患者的目的。 3) 评估临床应用价值 —— 评估所发现的生物标志物组合及其对应的预测模型在早期诊断、疾病分期、预后判断、治疗反应监测等方面的临床效用，包括但不限于灵敏度、特异性、阳性预测值、阴性预测值、受试者工作特征曲线（ROC曲线）下的面积（AUC）等评价指标。 4) 探索生物学机制 —— 结合已知的代谢通路知识，探讨鉴别出的生物标志物在肿瘤发生发展中的可能作用机制，为理解泌尿生殖系统肿瘤的病理生理过程提供新见解，并可能为未来治疗策略的制定提供理论依据。  

Objectives of Study：

1) Identifying specific biomarkers - Systematically analyzing the plasma metabolome of patients with urogenital system tumors and healthy controls, identifying differential metabolites closely related to tumor occurrence, these metabolites are expected to serve as potential biomarkers for clinical practice. 2) Build predictive models - Apply machine learning methods to train and validate classification models based on the plasma metabolism data of known cases and controls, with the aim of efficiently and accurately identifying patients with various urogenital system tumors. 3) Evaluate clinical application value - Assess the clinical utility of the discovered biomarker combinations and their corresponding predictive models in early diagnosis, disease staging, prognosis judgment, treatment response monitoring, etc. Including but not limited to evaluation indicators such as sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (ROC curve) (AUC). 4) Explore biological mechanisms - By integrating known knowledge of metabolic pathways, explore the possible mechanisms of action of identified biomarkers in tumorigenesis and development, providing new insights into the pathophysiological processes of urogenital system tumors and potentially offering theoretical basis for the formulation of future treatment strategies.

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) 病例组纳入标准： a.年龄≥18岁且＜75岁。 b.经病理学检查确诊为前列腺癌/膀胱癌/肾癌。 c.有足够的临床资料，包括病理报告、影像学检查结果等。 d.具有稳定的全身状况，如心率、血压、血氧饱和度等生命体征正常，血常规、生化、凝血功能等实验室检查结果在可接受范围内。 e.患者愿意参与研究并签署知情同意书。
2) 健康对照组纳入标准： a.年龄≥18岁且＜75岁。 b.通过详细的医疗史询问、体格检查、必要的实验室检查（如全血计数、生化分析等）和影像学筛查（如胸部X线或CT），确保参与者无其他慢性疾病或重大健康问题。 c.患者愿意参与研究并签署知情同意书。 d.无严重的内科疾病或精神疾病，身体状况适合进行代谢组学研究。
3) 良性疾病干扰组纳入标准： a.年龄≥18岁且＜75岁。 b.患有与泌尿生殖系统肿瘤症状相似的良性疾病，如良性前列腺增生、肾结石、尿路感染、良性肿瘤等。 c.有足够的临床资料，包括病理报告、影像学检查结果等。 d.具有稳定的全身状况，如心率、血压、血氧饱和度等生命体征正常，血常规、生化、凝血功能等实验室检查结果在可接受范围内。 e.患者愿意参与研究并签署知情同意书。

Inclusion criteria

1) Inclusion criteria for the case group: a. Age >=18 years and < 75 years. b. Confirmed by pathological examination as prostate cancer/bladder cancer/kidney cancer. c. There are sufficient clinical data, including pathological reports, imaging examination results, etc. d. Have a stable overall condition, with normal vital signs such as heart rate, blood pressure, and blood oxygen saturation, and laboratory test results such as blood routine, biochemistry, and coagulation function within an acceptable range. e. The patient is willing to participate in the study and sign the informed consent form. 2) Inclusion criteria for the healthy control group: a. Age >=18 years and < 75 years. b. Through detailed medical history inquiries, physical examinations, necessary laboratory tests (such as complete blood counts, biochemical analyses, etc.) and imaging screenings (such as chest X-rays or CT scans), ensure that participants have no other chronic diseases or major health issues. c. The patient is willing to participate in the study and sign the informed consent form. d. There are no serious internal or mental diseases, and the physical condition is suitable for metabolomics research. 3) Inclusion criteria for the benign disease interference group: a. Age >=18 years and < 75 years. b. Suffering from benign diseases with symptoms similar to those of urogenital system tumors, such as benign prostatic hyperplasia, kidney stones, urinary tract infections, benign tumors, etc. c. There are sufficient clinical data, including pathological reports, imaging examination results, etc. d. Have a stable overall condition, with normal vital signs such as heart rate, blood pressure, and blood oxygen saturation, and laboratory test results such as blood routine, biochemistry, and coagulation function within an acceptable range. e. The patient is willing to participate in the study and sign the informed consent form.

排除标准：

1) 病例组排除标准： a.受试者除前列腺癌/膀胱癌/肾癌外，患有严重影响血浆代谢谱的重大疾病，如严重的肝脏或肾脏疾病、糖尿病未控制、严重感染、艾滋病、自身免疫性疾病或其他并发恶性肿瘤等。 b.接受过针对前列腺癌/膀胱癌/肾癌的任何治疗，包括化疗、放疗、靶向治疗等。 c.伴有其他恶性肿瘤，除非是已经治愈超过5年的皮肤基底细胞癌或鳞状细胞癌。 d.有精神疾病史、药物滥用史、药物依赖史。 e.近7天内接受过手术者。 f.近7天内献血或大量出血（＞450mL），或接受输血或者使用血制品者。 g.妊娠试验阳性、哺乳期妇女。 h.研究者认为的其他原因不适合入组的受试者。
2) 健康对照组排除标准： a.存在任何类型恶性肿瘤的病史。 b.存在严重感染、营养不良、重度贫血等严重影响代谢组学检测结果的状况。 c.患有影响免疫功能或代谢的慢性疾病，如艾滋病、自身免疫性疾病、糖尿病未得到有效控制等。 d.近6个月内有长期用药史。 e.有精神疾病史、药物滥用史、药物依赖史。 f.近3个月内接受过手术者。 g.近3个月内献血或大量出血（＞450mL），或接受输血或者使用血制品者。 h.妊娠试验阳性、哺乳期妇女。 i. 研究者认为的其他原因不适合入组的受试者。
3) 良性疾病干扰组排除标准： a.经充分评估受试者患有恶性肿瘤，尤其是泌尿生殖系统恶性肿瘤。 b.存在严重影响代谢或免疫功能的其他重大疾病，如终末期肾病、肝硬化、自身免疫疾病、糖尿病未控制等。 c.有精神疾病史、药物滥用史、药物依赖史。 d.近3个月内接受过手术者。 e.近3个月内献血或大量出血（＞450mL），或接受输血或者使用血制品者。 f.妊娠试验阳性、哺乳期妇女。 g.研究者认为的其他原因不适合入组的受试者。

Exclusion criteria：

1) Exclusion criteria for the case group: a. The subjects, in addition to prostate cancer/bladder cancer/kidney cancer, have major diseases that seriously affect the plasma metabolic profile, such as severe liver or kidney diseases, uncontrolled diabetes, severe infections, AIDS, autoimmune diseases or other concurrent malignant tumors, etc. b. Has received any treatment for prostate cancer/bladder cancer/kidney cancer, including chemotherapy, radiotherapy, targeted therapy, etc. c. Accompanied by other malignant tumors, unless it is basal cell carcinoma or squamous cell carcinoma of the skin that has been cured for more than 5 years. d. Has a history of mental illness, drug abuse, or drug dependence. e. Those who have received manual surgery within the past 7 days. f. Those who have donated blood or suffered heavy bleeding (> 450mL) within the past 7 days, or have received blood transfusion or used blood products. g. Positive pregnancy test results and lactating women. h. Subjects who are not suitable for enrollment for other reasons as considered by the researchers.
2) Exclusion criteria for the healthy control group: a. History of any type of malignant tumor. b. There are severe infections, malnutrition, severe anemia and other conditions that seriously affect the results of metabolomics tests. c. Suffering from chronic diseases that affect immune function or metabolism, such as AIDS, autoimmune diseases, diabetes that have not been effectively controlled, etc. d. There has been a long-term medication history within the past six months. e. There is a history of mental illness, drug abuse, or drug dependence. f. Those who have undergone manual surgery within the last three months. g. Those who have donated blood or suffered significant bleeding (> 450mL) within the past three months, or have received blood transfuses or used blood products. h. Positive pregnancy test and lactating women. i. Subjects who are not suitable for enrollment for other reasons as considered by the researchers.
3) Exclusion criteria for the benign disease interference group: a. After thorough assessment, the subjects were found to have malignant tumors, especially those in the urogenital system. b. There are other major diseases that seriously affect metabolism or immune function, such as end-stage renal disease, liver cirrhosis, autoimmune diseases, uncontrolled diabetes, etc. c. There is a history of mental illness, drug abuse, or drug dependence. d. Those who have undergone manual surgery within the last three months. e. Those who have donated blood or suffered significant bleeding (more than 450mL) within the last three months, or have received blood transfusion or used blood products. f. Positive pregnancy test results and lactating women. g. Subjects who are not suitable for enrollment for other reasons as considered by the researcher.

研究实施时间：

Study execute time：

从 From 2025-04-30 00:00:00至 To 2027-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-31 00:00:00 至 To 2026-05-31 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）：

组织病理

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):

Histopathology

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）：

血浆非靶向代谢组学检测

Index test:

Plasma non-targeted metabolomics detection

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）

泌尿生殖系统癌患者

例数:

Sample size:

600

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 urogenital system cancer

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）：

患有相似症状的泌尿生殖系统良性疾病，如占位性病变、炎症、或存尿血尿痛等症状的患者； 健康人群。

例数:

Sample size:

400

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

Patients with benign urogenital system diseases with similar symptoms, such as space-occupying lesions, inflammation, or symptoms like hematuria and dysuria; Healthy population.

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

华中科技大学同济医学院附属协和医院 

单位级别：

三级甲等 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

受试者工作区线下面积

指标类型：

主要指标

Outcome：

Area Under Curve

Type：

Primary indicator

测量时间点：

测量方法：

绘制受试者工作曲线（receiver operating characteristic curve），计算受试者工作曲线下面积（AUC）。

Measure time point of outcome：

Measure method：

Draw the receiver operating characteristic curve and calculate the area under the receiver operating characteristic curve (AUC).

指标中文名：

敏感性

指标类型：

主要指标

Outcome：

Sensitivity

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

特异性

指标类型：

主要指标

Outcome：

Specificity

Type：

Primary 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：

血浆

组织：

Sample Name：

plasma

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 18 岁 years
最大 Max age 74 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

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）：

研究者计划将在研究完成后1年内，将相关研究数据以论文形式发表。研究者将向期刊提交相关研究数据，包括脱敏后的受试者临床信息，本研究涉及的代谢组学检测信息，以及统计分析得到的结果。公众可通过联系期刊或者邮件联系主要研究者获得研究相关的数据。

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

The researchers plan to publish the relevant research data in the form of a paper within one year after the completion of the study. The researchers will submit relevant research data to the journal, including the clinical information of the subjects after desensitization, the metabolomics detection information involved in this study, and the results obtained from statistical analysis. The public can obtain research-related data by contacting the journal or the principal investigator via email.

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：

使用病例报告表收集和管理数据

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

Collect and manage data using case report forms

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-08-13 08:57:01