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乳痛症及乳腺结节多中心平行对照研究及组织学“乳腺增生”真实比例及其癌变危险因素临床研究
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注册号:

Registration number:

ChiCTR1900024100 

最近更新日期:

Date of Last Refreshed on:

2019-06-25 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

乳痛症及乳腺结节多中心平行对照研究及组织学“乳腺增生”真实比例及其癌变危险因素临床研究 

Public title:

A multicentre parallel control study of breast pain and breast nodules and the true proportion of histology  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

乳痛症及乳腺结节多中心平行对照研究 

Scientific title:

A multicentre parallel control study of breast pain and breast nodules 

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:

郑新宇 

研究负责人:

郑新宇 

Applicant:

Xinyu Zheng 

Study leader:

Xinyu Zheng 

申请注册联系人电话:

Applicant telephone:

+86 024-83282741 

研究负责人电话:

Study leader's telephone:

+86 024-83282741 

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:

xyzheng@cmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xyzheng@cmu.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:

辽宁省沈阳市和平区南京北街155号 

研究负责人通讯地址:

辽宁省沈阳市和平区南京北街155号 

Applicant address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, China 

Study leader's address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, China 

申请注册联系人邮政编码:

Applicant postcode:

110001 

研究负责人邮政编码:

Study leader's postcode:

110001 

申请人所在单位:

中国医科大学附属第一医院 

Applicant's institution:

First Affiliated Hospital, China Medical University 

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:

AF-S0P-07-1.1-01 

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:

中国医科大学附属第一医院医学科学研究伦理委员会 

Name of the ethic committee:

Medical Science Research Ethics Committee of the First Affiliated Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-15 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

辽宁省沈阳市和平区南京北街155号 

Contact Address of the ethic committee:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, China 

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:

中国医科大学附属第一医院 

Primary sponsor:

First Affiliated Hospital, China Medical University 

研究实施负责(组长)单位地址:

辽宁省沈阳市和平区南京北街155号 

Primary sponsor's address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, 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):

辽宁省

市(区县):

沈阳市

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属第一医院

具体地址:

和平区南京北街155号

Institution
hospital:

First Affiliated Hospital, China Medical University

Address:

155 Nanjing Street North, Heping District

经费或物资来源:

中国健康促进基金会乳腺癌防治专项基金管理委员会 

Source(s) of funding:

China health promotion foundation breast cancer prevention special fund management committee 

研究疾病:

乳痛症及乳腺结节 

Target disease:

mastalgia and breast nodules 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

(1)研究和探讨辽宁地区人群乳痛症及组织学乳腺增生的流行病学特点,及相关危险因素,筛选预警评估指标。 (2)验证解释安慰(reassurance)心理干预对于乳痛症的治疗及缓解效果 (3)验证常用乳痛症干预药物“平消胶囊”等中成药对于乳腺纤维囊性改变的治疗效果和对于乳腺癌预防作用的效果及可行性。 (4)为辽宁地区多中心课题提供有效的研究数据,探索和完善一整套符合辽宁地区人群特点的乳痛症个体筛查与干预管理方案。 (5) 调查辽宁地区乳腺穿刺活检或切除活检中病理回报为“乳腺增生”的真实比例,从而规范临床“乳腺增生”的诊断以及乳腺穿刺活检或者切除活检的指征。 

Objectives of Study:

(1) To study and explore the epidemiological characteristics of mastalgia and histological breast hyperplasia in Liaoning population, and related risk factors, and screen early warning evaluation indicators. (2) To verify and interpretate the effect of reassurance psychological intervention for the treatment and relief of mastalgia. (3) To verify the therapeutic effect of Chinese patent medicines such as Pingxiao Capsule, which is a commonly used intervention drug for mastalgia, on the fibrocystic changes of breast and its effect and feasibility on the prevention of breast cancer. (4) Provide effective research data for multi-center projects in Liaoning. To explore and improve a set of individual screening and intervention management programs for mastalgia that meet the characteristics of people in Liaoning. (5) To investigate the true proportion of pathological mammary hyperplasia in breast biopsy or excisional biopsy in Liaoning, so as to standardize the diagnosis of clinical mammary hyperplasia and the indications of breast biopsy or excisional biopsy.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)性别:女 (2)年龄≥30岁; (3)在过去三个月内患者有可感知的周期性或非周期性乳房疼痛和/或超声提示结节样改变并超声,钼靶,磁共振排除乳腺良恶性肿瘤者。 

Inclusion criteria

(1) Gender: Female (2) Aged 30 years and above; (3) In the past three months, patients have perceptible periodic or non-periodic breast pain and/or ultrasound suggesting nodular changes with exclusion of benign and malignant breast tumors by ultrasound, mammography, and magnetic resonance. 

排除标准:

(1)既往或目前明确诊断有乳腺肿瘤(包括乳腺癌和乳腺良性肿瘤)或乳腺及慢性炎症的患者; (2)既往有乳腺外伤,冠心病,急慢性肺部炎症,肿瘤结核,及神经官能症者; (3)妊娠期或哺乳期女性。 

Exclusion criteria:

(1) Patients who have previously or currently been diagnosed breast tumors (including breast cancer and benign breast tumors) or breast acute and chronic inflammation; (2) Patients who have breast trauma, coronary heart disease, acute and chronic pulmonary inflammation, tumor, tuberculosis, and psychoneurosis previously; (3) Pregnant or lactating women. 

研究实施时间:

Study execute time:

From2018-07-01To 2023-06-30 

干预措施:

Interventions:

组别:

心理干预组

样本量:

1000

Group:

psychological intervention

Sample size:

干预措施:

心理干预

干预措施代码:

Intervention:

psychological intervention

Intervention code:

组别:

药物干预组

样本量:

1000

Group:

pharmacological intervention

Sample size:

干预措施:

药物干预

干预措施代码:

Intervention:

pharmacological intervention

Intervention code:

组别:

对照组

样本量:

1000

Group:

control group

Sample size:

干预措施:

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):

辽宁省 

市(区县):

沈阳市 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital, China Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

沈阳市 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属盛京医院 

单位级别:

三级甲等 

Institution
hospital:

Shengjing Affiliated Hospital, China Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

沈阳市 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

Fourth Affiliated Hospital, China Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

沈阳市 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

辽宁省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Liaoning Cancer Hospital and Institute  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

乳痛症患者问卷调查

指标类型:

主要指标 

Outcome:

questionnaire survey

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声

指标类型:

主要指标 

Outcome:

ultrasonography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

触诊

指标类型:

主要指标 

Outcome:

palpation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学检查

指标类型:

主要指标 

Outcome:

imageological examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

穿刺组织学活检

指标类型:

主要指标 

Outcome:

biopsy

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:

乳腺结节

组织:

Sample Name:

breast nodules

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 30 years
最大 Max age 60 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):

由研究人员按照“随机,双盲”原则并通过SPSS软件随机分组将受试者平均分为心理干预组,“平消胶囊”干预组及对照组。

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

Subjects were randomly divided into psychological intervention group, “Pingxiao Capsule” intervention group and control group according to the “random, double-blind” principle and randomized grouping by SPSS software.

盲法:

双盲 请说明施盲对象?

Blinding:

Double blind

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

不公开

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

Private

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:

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-25
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