ChiCTR2500115848 版本V1.0 版本创建时间2025/12/31 16:44:36 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：

ChiCTR2500115848 

最近更新日期：

Date of Last Refreshed on：

2025-12-31 16:44:30 

注册时间：

Date of Registration：

2025-12-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

妇科恶性肿瘤瘤内微生态变化影响肿瘤发生发展及患者预后的机制研究

Public title：

Mechanism Research on the Influence of Intratumoral Microecological Changes in Gynecological Oncology on Tumor Occurrence, Development and Patient Prognosis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

妇科恶性肿瘤瘤内微生态变化影响肿瘤发生发展及患者预后的机制研究

Scientific title：

Mechanism Research on the Influence of Intratumoral Microecological Changes in Gynecological Oncology on Tumor Occurrence, Development and Patient Prognosis

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：

刘佳 

研究负责人：

赵成志 

Applicant：

Jia Liu 

Study leader：

Chengzhi Zhao 

申请注册联系人电话：

Applicant telephone：

+86 151 2331 3325

研究负责人电话：

Study leader's telephone：

+86 23 6370 2844

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：

1821552619@qq.com

研究负责人电子邮件：

Study leader's E-mail：

330808042@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：

重庆市渝北区龙山路 120 号

研究负责人通讯地址：

龙山路120号

Applicant address：

No. 120, Longshan Road, Yubei District, Chongqing

Study leader's address：

No 120 Longshan Road, Yubei District, Chongqing.

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：

重庆市妇幼保健院

Applicant's institution：

Chongqing Health Center for Women and Children

研究负责人所在单位：

重庆市妇幼保健院

Affiliation of the Leader：

Chongqing Health Center for Women and Children

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(科)129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：

重庆市妇幼保健院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Chongqing Health Center for Women and Children

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-12 00:00:00

伦理委员会联系人：

贺凌云

Contact Name of the ethic committee：

Lingyun He

伦理委员会联系地址：

龙山路120号

Contact Address of the ethic committee：

No 120 Longshan Road, Yubei District, Chongqing.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 23 6331 6835

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hly.1023@163.com

研究实施负责（组长）单位：

重庆市妇幼保健院

Primary sponsor：

Chongqing Health Center for Women and Children

研究实施负责（组长）单位地址：

龙山路120号

Primary sponsor's address：

No 120 Longshan Road, Yubei District, Chongqing.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆市妇幼保健院

具体地址：

龙山路120号

Institution
hospital：

Chongqing Health Center for Women and Children

Address：

No 120 Longshan Road, Yubei District, Chongqing.

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected Project (Self-funded)

Target disease：

Cervical cancer; Ovarian cancer; Endometrial cancer; Cervical (os) polyp; Cervical myoma; Cervical intraepithelial neoplasia; Benign tumors of the ovary/fallopian tube; Ovarian/fallopian tube cysts; Endometrial polyp; Uterine leiomyoma; Simple/complex/atypical hyperplasia of the endometrium

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：

本研究聚焦宫颈癌、卵巢癌、子宫内膜癌三大妇科恶性肿瘤，旨在系统探究不同类型妇科恶性肿瘤瘤内微生态的特异性变化，深入解析这些微生态改变调控肿瘤细胞增殖、免疫逃逸及转移的病理机制，明确其对肿瘤发生发展进程及患者预后的具体影响。同时，基于研究结果挖掘潜在的肿瘤诊断微生物标志物与治疗靶点，弥补当前妇科恶性肿瘤微生态机制研究的不足，为临床制定精准化、个性化的诊疗方案，提升疾病诊治效果、改善患者预后提供进一步的理论依据与实践指导。  

Objectives of Study：

This study focuses on three major gynecological malignant tumors: cervical cancer, ovarian cancer, and endometrial cancer. It aims to systematically explore the specific changes in the intratumoral microecology of different types of gynecological malignant tumors, deeply analyze the pathological mechanisms by which these microecological changes regulate tumor cell proliferation, immune escape, and metastasis, and clarify their specific impacts on the process of tumor occurrence and development as well as patient prognosis. Meanwhile, based on the research results, it will explore potential microbial markers for tumor diagnosis and therapeutic targets, make up for the deficiencies in the current research on the microecological mechanisms of gynecological malignant tumors, and provide further theoretical basis and practical guidance for formulating precise and personalized clinical diagnosis and treatment plans, improving the efficacy of disease diagnosis and treatment, and enhancing patient prognosis.

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.妇科恶性肿瘤患者：经病理组织学确诊为妇科恶性肿瘤；年满18周岁；预计生存期≥3个月；对整个研究知情理解并签署知情同意书，自愿入组的患者。
2.妇科良性肿瘤患者：经病理组织学确诊为妇科良性肿瘤；年满18周岁；对整个研究知情理解并签署知情同意书，自愿入组的患者。
3.健康体检者：年满18周岁；最近3月内无便秘或者腹泻等消化系统症状；对整个研究知情理解并签署知情同意书，自愿入组的志愿者。

Inclusion criteria

1.Patients with gynecological malignant tumors: Patients who have been diagnosed with gynecological malignant tumors by histopathological examination; are at least 18 years old; have an expected survival period of ≥ 3 months; have understood the entire study, signed the informed consent form, and voluntarily enrolled in the study.
2.Patients with benign gynecological tumors: Patients who have been diagnosed with benign gynecological tumors by histopathological examination; are at least 18 years old; have understood the entire study, signed the informed consent form, and voluntarily joined the group.
3.Health check-up participants: volunteers who are at least 18 years old; have no digestive system symptoms such as constipation or diarrhea within the recent 3 months; have understood the entire study, signed the informed consent form, and voluntarily joined the group.

排除标准：

1.妇科恶性肿瘤患者：合并其他恶性肿瘤疾病；同时患有炎症性肠病或其他免疫性疾病；合并严重的心、肝、肾等重要脏器功能障碍；近1个月内使用过抗生素、益生菌等可能影响微生态的药物；存在精神疾病或认知障碍，无法配合完成研究；拒绝参加本研究或不配合随访者。
2.妇科良性肿瘤患者：合并炎症性肠病或其他免疫性疾病；合并严重的心、肝、肾等重要脏器功能障碍；近1个月内使用过抗生素、益生菌等可能影响微生态的药物；存在精神疾病或认知障碍，无法配合完成研究；拒绝参加本研究或不配合随访者。
3.健康体检者：合并炎症性肠病或其他免疫性疾病；患有其他消化系统疾病；消化系统手术史；近1个月内使用过抗生素、益生菌等可能影响微生态的药物。

Exclusion criteria：

1.Patients with gynecological malignant tumors: those with other concurrent malignant tumor diseases; those with inflammatory bowel disease or other immune diseases; those with severe dysfunction of important organs such as the heart, liver, and kidneys; those who have used antibiotics, probiotics, or other drugs that may affect the microecology within the past month; those with mental illness or cognitive impairment who cannot cooperate in completing the study; those who refuse to participate in this study or fail to cooperate with follow-up.
2.Patients with benign gynecological tumors: those with comorbid inflammatory bowel disease or other immune diseases; those with severe dysfunction of important organs such as the heart, liver, and kidneys; those who have used antibiotics, probiotics, or other drugs that may affect the microecology within the past month; those with mental illness or cognitive impairment who cannot cooperate in completing the study; those who refuse to participate in this study or do not cooperate with follow-up.
3.Health check-up participants: those with comorbid inflammatory bowel disease or other immune diseases; those with other digestive system diseases; those with a history of digestive system surgery; those who have used antibiotics, probiotics, or other drugs that may affect the microecology within the past month.

研究实施时间：

Study execute time：

从 From 2025-12-24 00:00:00至 To 2030-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-31 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

病例组（瘤内微生态群落）

样本量：

300

Group：

Case group (Intratumoral microecological community)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

对照组 （微生态群落）

样本量：

241

Group：

Control group (Microecological community)

Sample size：

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)：

 重庆市 

市(区县)：

  

Country：

China 

Province：

Chongqing 

City：

 

单位(医院)：

重庆市妇幼保健院 

单位级别：

三级甲等 

Institution
hospital：

Chongqing Health Center for Women and Children

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

外部对照差异

指标类型：

次要指标

Outcome：

External control differences

Type：

Secondary indicator

测量时间点：

组织样本、分泌物样本、粪便样本采集后1周

测量方法：

ITS 基因测序、宏基因组 shotgun 测序

Measure time point of outcome：

Within one week after the collection of tissue samples, secretion samples, and fecal samples

Measure method：

ITS gene sequencing, metagenomic shotgun sequencing

指标中文名：

癌灶组织与邻近组织的瘤内微生态多样性差异

指标类型：

主要指标

Outcome：

Differences in intratumoral microecological diversity between cancerous tissue and adjacent tissue

Type：

Primary indicator

测量时间点：

组织样本、分泌物样本、粪便样本采集后1周

测量方法：

ITS 基因测序、宏基因组 shotgun 测序

Measure time point of outcome：

Within one week after the collection of tissue samples, secretion samples, and fecal samples

Measure method：

ITS gene sequencing, metagenomic shotgun sequencing

指标中文名：

临床病理关联

指标类型：

次要指标

Outcome：

Clinicopathological correlation

Type：

Secondary indicator

测量时间点：

样本测序结果收集后2周

测量方法：

收集患者微生物群落测学结果及病理学结果报告，采用卡方检验/方差分析、PERMANOVA /多因素线性回归等统计方法

Measure time point of outcome：

Two weeks after the sample sequencing results are collected

Measure method：

Collect the patients' microbiome sequencing results and pathological result reports, and adopt statistical methods such as chi-square test/analysis of variance, PERMANOVA/multivariate linear regression.

指标中文名：

微生态组成差异

指标类型：

次要指标

Outcome：

Differences in microecological composition

Type：

Secondary indicator

测量时间点：

组织样本、分泌物样本、粪便样本采集后1周

测量方法：

ITS 基因测序、宏基因组 shotgun 测序

Measure time point of outcome：

Within one week after the collection of tissue samples, secretion samples, and fecal samples

Measure method：

ITS gene sequencing, metagenomic shotgun sequencing

指标中文名：

患者预后

指标类型：

次要指标

Outcome：

patients' prognostic

Type：

Secondary indicator

测量时间点：

5年随访结束后

测量方法：

复发：采用方差分析或T检验分析复发率，采用卡方检验分析复发类型； 生存结局：采用生存分析方法，分别分析?PFS、OS

Measure time point of outcome：

After the 5-year follow-up ended

Measure method：

Recurrence: Analysis of recurrence rate using analysis of variance or T-test, and analysis of recurrence type using chi-square test; Survival outcomes: Using survival analysis methods to analyze PFS and OS respectively

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织样本

组织：

Sample Name：

Tissue sample

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便样本

组织：

Sample Name：

fecal sample

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

分泌物样本

组织：

Sample Name：

secretion sample

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 岁 years

性别：

女性

Gender：

Female

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

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）：

数据不共享

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

Data is not shared.

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：

1.CRF管理：采用标准化定制表格，采集内容含受试者基线临床信息（年龄、肿瘤类型/分期等）、样本采集信息（组织/分泌物/粪便的采集部位、时间、保存方式）、实验室检测数据（微生物测序数据、微生态分析结果）及随访数据（生存状态、复发情况），由培训后研究人员双盲录入，确保数据准确性； 2.EDC管理：使用合规电子数据系统，对CRF数据进行电子化录入、实时逻辑校验、权限分级管控（录入/审核/管理权限分离），定期备份数据，同时留存CRF纸质版作为原始数据存档。

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

1.CRF management: A standardized customized form is used to collect data including subjects' baseline clinical information (age, tumor type/stage, etc.), sample collection information (collection site, time and preservation method of tissue/secretion/stool samples), laboratory test data (microbial sequencing data, microecological analysis results) and follow-up data (survival status, recurrence). The data is double-blind entered by trained researchers to ensure accuracy; 2.EDC management: A compliant electronic data system is adopted for electronic entry of CRF data, real-time logical verification, hierarchical permission control (separation of entry/audit/management permissions), regular data backup, and paper CRF is retained as original data archive.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-12-31 16:44:30