“芪术方”改善乳腺癌巨噬细胞相关免疫微环境的随机、双盲、对照研究

注册号:

Registration number:

ITMCTR2200005630

最近更新日期:

Date of Last Refreshed on:

2022-02-10

注册时间:

Date of Registration:

2022-02-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

“芪术方”改善乳腺癌巨噬细胞相关免疫微环境的随机、双盲、对照研究

Public title:

The Study of Qi Zhu fang Fomula Improves the Immune Microenvironment Related to Breast Cancer Macrophages: a randomized, double-blind, placebo-controlled study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

“芪术方”改善乳腺癌巨噬细胞相关免疫微环境的随机、双盲、对照研究

Scientific title:

The Study of Qi Zhu fang Fomula Improves the Immune Microenvironment Related to Breast Cancer Macrophages: a randomized, double-blind, placebo-controlled study

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:

ChiCTR2200056658 ; ChiMCTR2200005630

申请注册联系人:

董梦婷

研究负责人:

江科

Applicant:

MengTing Dong

Study leader:

Ke Jiang

申请注册联系人电话:

Applicant telephone:

13817170419

研究负责人电话:

Study leader's telephone:

13301617893

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:

nancyd33@163.com

研究负责人电子邮件:

Study leader's E-mail:

surgeonjk@163.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:

上海市虹口区甘河路110号岳阳医院

研究负责人通讯地址:

上海市虹口区甘河路110号岳阳医院

Applicant address:

No. 110 Gan he road, Hongkou District, Shanghai

Study leader's address:

No. 110 Gan he road, Hongkou District, Shanghai

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:

上海中医药大学附属岳阳中西医结合医院

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional 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:

2021-140

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee:

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/1/17 0:00:00

伦理委员会联系人:

殷从全

Contact Name of the ethic committee:

Yin Cong-quan

伦理委员会联系地址:

上海市虹口区甘河路110号

Contact Address of the ethic committee:

No. 110 Gan he road, Hongkou District, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号

Primary sponsor's address:

No. 110 Gan he road, Hongkou District, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address:

No. 110 Gan he road, Hongkou District, Shanghai

经费或物资来源:

上海市卫生健康委员会科研项目

Source(s) of funding:

Shanghai Municipal Health Commission

研究疾病:

乳腺恶性肿瘤

研究疾病代码:

Target disease:

Breast Cancer

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

(1)明确 APOC3 是乳腺恶性肿瘤巨噬细胞 M2 极化的关键调控点; (2)证实“芪术方”通过 APOC3 抑制巨噬细胞 M2 极化,调控乳腺癌免疫微环境。

Objectives of Study:

(1)To clear that APOC3 is a key regulator of M2 polarization in breast cancer macrophages; (2)To confirm that Qi Zhu fang Fomula inhibits the M2 polarization of macrophages through APOC3, and regulates the immune microenvironment of breast cancer.

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女性,年龄≥18岁且≤70 岁; ②乳腺 B 超、钼靶、核磁共振检查,至少一项检查结果 BI-RADS 分级为 4B 或以上,乳腺专科医师判断需要手术或者穿刺者; ③未接受过任何肿瘤相关治疗,包括手术、放化疗、内分泌治疗、免疫治疗等; ④中医辨证分型属于气虚血瘀型; ⑤经患者知情同意。

Inclusion criteria

①Female, aged ≥18 years old and ≤70 years old; ② Breast B-ultrasound, mammography, MRI, at least one of the results of BI-RADS grading is 4B or above, and the breast specialist judges that surgery or puncture is necessary; ③ Have not received any tumor-related treatment, including surgery, radiotherapy and chemotherapy, endocrine therapy, immunotherapy, etc.; ④ TCM syndrome differentiation belongs to the type of Qi deficiency and blood stasis; ⑤ With the informed consent of the patient.

排除标准:

①因患有精神疾患等无法合作者; ②合并严重的循环系统、呼吸系统、消化系统、血液系统、泌尿系统、神经系统、内分泌系统疾病,研究者认为该患者其他系统的严重疾病将影响本研究结果者; ③拒绝手术和/或穿刺者; ④有乳腺癌远处转移者; ⑤已知患有任意其他恶性肿瘤者; ⑥同期参与其他临床研究者; ⑦处于妊娠或哺乳期者; ⑧因过敏等原因无法服用中药者; ⑨实验之前近三个月有规律服用中药者(每周服用≥5天,间断≤7天)。

Exclusion criteria:

① Those who are unable to cooperate due to mental illness, etc.; ② Patients with serious diseases of the circulatory system, respiratory system, digestive system, blood system, urinary system, nervous system, and endocrine system, and the researchers believe that the serious diseases of the patient's other systems will affect the results of this study; ③ Those who refuse surgery and/or puncture; ④ Patients with distant metastasis of breast cancer; ⑤ Known to suffer from any other malignant tumor; ⑥ Participate in other clinical investigators during the same period; ⑦ Those who are pregnant or breastfeeding; ⑧ Those who cannot take traditional Chinese medicine due to allergies or other reasons; ⑨ Those who regularly took traditional Chinese medicine in the past three months before the experiment (≥5 days per week, ≤7 days intermittently).

研究实施时间:

Study execute time:

From 2022-01-01

To      2024-01-31

征募观察对象时间:

Recruiting time:

From 2022-04-01

To      2024-03-31

干预措施:

Interventions:

组别:

安慰剂组

样本量:

80

Group:

Placebo Group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

芪术方组

样本量:

80

Group:

Qi Zhu fang Fomula Group

Sample size:

干预措施:

芪术方

干预措施代码:

Intervention:

Qi Zhu fang Fomula

Intervention code:

样本总量 Total sample size : 160

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三级甲等医院

Institution/hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution:

3A hospital

测量指标:

Outcomes:

指标中文名:

良、恶性肿瘤 APOC3 及巨噬细胞 M1、M2 表达情况

指标类型:

次要指标

Outcome:

Expression of APOC3 and macrophage M1 and M2 in benign and malignant tumors

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中药对良、恶性肿瘤 APOC3 及巨噬细胞 M1、M2 表达影响的区别

指标类型:

次要指标

Outcome:

The difference between the effects of traditional Chinese medicine on the expression of APOC3 and macrophage M1 and M2 in benign and malignant tumors

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中药对恶性肿瘤APOC3与巨噬细胞M1,M2表达改变率

指标类型:

主要指标

Outcome:

Changes in the expression of APOC3 and macrophages M1, M2 by traditional Chinese medicine in malignant tumors

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性指标

指标类型:

次要指标

Outcome:

Safety index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶性肿瘤APOC3与巨噬细胞M1,M2表达间关系

指标类型:

主要指标

Outcome:

The relationship between the expression of APOC3 in malignant tumors and the expression of M1 and M2 in macrophages

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:

癌肿组织

组织:

乳腺癌

Sample Name:

tumor tissue

Tissue:

人体标本去向

使用后保存

说明

检测后剩余标本将保存于岳阳医院病理科

Fate of sample 

Preservation after use

Note:

标本中文名:

血液

组织:

外周血

Sample Name:

Blood

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

按照研究方案,计划入组 160 例,按照1:1比例,分为芪术方组和安慰剂组。①分组人员拟定 160 个研究对象序号;②随机数字表法产生随机数字;③规定随机数字为奇数的研究对象分到芪术方组,偶数的分到安慰剂组;④留存随机分配方案的文件。

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

According to the research protocol, 160 patients were planned to be enrolled and according to the ratio of 1:1: divided into a Qi Zhu fang Fomula group and a placebo group. ①The serial numbers of 160 subjects were drawn up by grouping staff; ②The random number table method was used to gener

盲法:

采用双盲设计,两级设盲建立随机编码表,密封后交由岳阳医院保存。按上述盲底对药品进行分装编盲。为每个受试者分配一个药盒,药盒种包含治疗期内所有的用药。药盒的标签上协商编号,盒内所有药品的标签上也写上相同的编号。还为每个病例准备一个应急信件,信封有病人的药物编号,密封的信纸内注明了该病例的所属组别,供紧急揭盲时用。实验室检测由专人负责,数据收集与统计由专人负责,检测者及统计人员均不知道试验分组及具体操作情况。

Blinding:

A double-blind design was adopted, with two levels of blinding to establish a random coding table, which was sealed and handed over to Yueyang Hospital for preservation. According to the above-mentioned blind base, the medicines are sub-packaged and blinded. Each subject was assigned a kit containing all medications during the treatment period. The number is negotiated on the label of the medicine box, and the same number is written on the label of all medicines in the box. An emergency letter is also prepared for each case, the envelope has the patient's drug number, and the group of the case is indicated in the sealed letter paper for emergency unblinding. The laboratory testing is carried out by a special person, and the data collection and statistics are carried out by a special person. Neither the testers nor the statisticians know the test grouping and the specific operation.

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):

不共享

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

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.通过纸质版CRF表采集数据 2.通过电子版EXCEL表管理数据。

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

1. Collect data through the paper version of the CRF table 2. Manage data through the electronic version of EXCEL

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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