基于miRNAs互作关系阐释中医湿毒虚整体干预胃癌前病变的优势人群表型差异及其机制

注册号:

Registration number:

ITMCTR2024000207

最近更新日期:

Date of Last Refreshed on:

2024-08-10

注册时间:

Date of Registration:

2024-08-10

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

基于miRNAs互作关系阐释中医湿毒虚整体干预胃癌前病变的优势人群表型差异及其机制

Public title:

To elucidate the phenotypic differences and mechanism of TCM dampness and toxin deficiency intervention in gastric precancerous lesions based on the interaction of miRNAs

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于miRNAs互作关系阐释中医湿毒虚整体干预胃癌前病变的优势人群表型差异及其机制

Scientific title:

To elucidate the phenotypic differences and mechanism of TCM dampness and toxin deficiency intervention in gastric precancerous lesions based on the interaction of miRNAs

研究课题的正式科学名称简写:

Scientific title acronym:

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:

徐嘉敏

研究负责人:

杨小波

Applicant:

Jianmin Xu

Study leader:

Xiaobo Yang

申请注册联系人电话:

Applicant telephone:

1562618487

研究负责人电话:

Study leader's telephone:

13825012636

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:

jiaminxu@gzucm.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

yangxiaobo39358517@hotmail.com

申请单位网址(自愿提供):

Study leader's 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:

广东省广州市大德路111号

研究负责人通讯地址:

广东省广州市大德路111号

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong 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:

广州中医药大学第二附属医院

Applicant's institution:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

BF2021-026-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

广东省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/4/2 0:00:00

伦理委员会联系人:

李晓彦

Contact Name of the ethic committee:

Xiaoyan Li

伦理委员会联系地址:

广东省广州市大德路111号

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

020-81887233-35943

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbgs@gzucm.edu.cn

研究实施负责(组长)单位:

广东省中医院

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责(组长)单位地址:

广东省广州市大德路111号

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广东省广州市大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

经费或物资来源:

广东省基础与应用基础研究基金委员会

Source(s) of funding:

Basic and Applied Basic Research Foundation of Guangdong Province

研究疾病:

胃癌前病变

研究疾病代码:

Target disease:

gastric precanerous

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

(1)建构与验证“从湿毒虚整体角度干预胃癌前病变对应优势表型的 miRNA 互作关系及机制”的假设,实现平胃建中化湿解毒治法防治胃癌前病变的科学阐释; (2)明确平胃建中化湿解毒治法的优势人群的整体表型及对应的miRNA互作关系机制,探索实现中医与西医、宏观与微观相结合的精准治疗,为目前中西医结合精准医疗提供一定的方法学借鉴。

Objectives of Study:

(1) To construct and verify the hypothesis of miRNA interaction and mechanism of corresponding dominant phenotypes of gastric precancerous lesions from the overall perspective of dampness and toxin deficiency, so as to achieve a scientific interpretation of the prevention and treatment of gastric precancerous lesions by adjusting dampness and detoxing therapy; (2) To clarify the overall phenotype of the dominant population and the corresponding miRNA interaction mechanism in the treatment of Hua-dampness and detoxification in the Pingwei construction, and to explore the implementation of precision treatment combining traditional Chinese medicine and western medicine, macro and micro, so as to provide certain methodology reference for the current precision medicine of integrated traditional Chinese and western medicine.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

诊断标准:胃黏膜癌前病变诊断标准:参照 2017年中华医学会《中国慢性胃炎共识意见》(上海),同时结合内窥镜与病理诊断,并以病理诊断为最终诊断依据,即慢性萎缩性胃炎伴肠化生或异型增生。 ① 符合上述诊断标准的患者知情并同意接受治疗者; ② 患者年龄35-65岁。

Inclusion criteria

Diagnostic criteria: precancerous lesions of gastric mucosa were defined as chronic atrophic gastritis with intestinal metaplasia or dysplasia according to the 2017 Chinese Medical Association Consensus on Chronic Gastritis (Shanghai), combined with endoscopic and pathological diagnosis, and the final diagnosis was based on pathological diagnosis. ① Patients who met the above diagnostic criteria were informed and agreed to receive treatment; ② The age of patients ranged from 35 to 65 years old.

排除标准:

①胃黏膜癌变者; ② 存在其他严重消化系统疾病者,如消化性溃疡、胃出血以及胆道、胰腺等器质性病变者; ③合并恶性肿瘤者; ④ 合并严重心、肺、肝、肾等系统疾病者; ⑤ 正参加或参加过其他临床试验结束尚未超过3个月者; ⑥妊娠或哺乳期妇女; ⑦ 存在严重的认知障碍者; ⑧ 研究者认为存在不适合参加本研究的其他情况。

Exclusion criteria:

Diagnostic criteria: precancerous lesions of gastric mucosa were defined as chronic atrophic gastritis with intestinal metaplasia or dysplasia according to the 2017 Chinese Medical Association Consensus on Chronic Gastritis (Shanghai), combined with endoscopic and pathological diagnosis, and the final diagnosis was based on pathological diagnosis. ① Patients who met the above diagnostic criteria were informed and agreed to receive treatment; ② The age of patients ranged from 35 to 65 years old. ① Gastric cancer; (2) patients with other serious digestive system diseases, such as peptic ulcer, gastric bleeding, biliary tract, pancreas and other organic lesions; ③ combined with malignant tumors; ④ Complicated with serious heart, lung, liver, kidney and other system diseases; ⑤ who are participating or participated in other clinical trials less than 3 months after completion; ⑥ pregnant or lactating women; ⑦ with severe cognitive impairment; ⑧ The investigator thought that there were other conditions that were not suitable for the study.

研究实施时间:

Study execute time:

From 2021-04-02

To      2023-04-02

征募观察对象时间:

Recruiting time:

From 2021-04-02

To      2023-04-02

干预措施:

Interventions:

组别:

常规治疗组

样本量:

49

Group:

usual care group

Sample size:

干预措施:

对症治疗

干预措施代码:

Intervention:

symptomatic treatment

Intervention code:

组别:

平胃建中化湿解毒法治疗组

样本量:

49

Group:

Pingwei Jianzhong Huashi Jiedu treatment group

Sample size:

干预措施:

口服平胃建中解毒方

干预措施代码:

Intervention:

Pingwei Jianzhong Jiedu prescription was given orally

Intervention code:

样本总量 Total sample size : 98

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

单位级别:

三甲

Institution/hospital:

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution:

3A

测量指标:

Outcomes:

指标中文名:

疗效评价

指标类型:

主要指标

Outcome:

therapeutic evaluation

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:

血液

组织:

Sample Name:

blood

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

组织:

Sample Name:

faeces

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:

结束

Completed

年龄范围:

最小 35
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

不采用随机方法

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

No random method was used

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):

ResMan

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

ResMan

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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