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Role of gut bacteria on the development of breast cancer
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注册号:

Registration number:

ChiCTR1800015320 

最近更新日期:

Date of Last Refreshed on:

2018-03-23 

注册时间:

Date of Registration:

2018-03-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Role of gut bacteria on the development of breast cancer 

Public title:

Role of gut bacteria on the development of breast cancer 

注册题目简写:

 

English Acronym:

Gut bacteria and breast cancer 

研究课题的正式科学名称:

A pilot study on the association between gut microbiota and development of breast cancer in Hong Kong Chinese 

Scientific title:

A pilot study on the association between gut microbiota and development of breast cancer in Hong Kong Chinese 

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:

Prof. Paul KS Chan 

研究负责人:

Prof. Paul KS Chan 

Applicant:

Prof. Paul KS Chan 

Study leader:

Prof. Paul KS Chan 

申请注册联系人电话:

Applicant telephone:

+852 35053339 

研究负责人电话:

Study leader's telephone:

+852 35053339 

申请注册联系人传真 :

Applicant Fax:

+852 26473227 

研究负责人传真:

Study leader's fax:

+852 26473227 

申请注册联系人电子邮件:

Applicant E-mail:

paulkschan@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

paulkschan@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cuhk.edu.hk/med/mic/People/Paul.html 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cuhk.edu.hk/med/mic/People/Paul.html 

申请注册联系人通讯地址:

中國香港沙田威爾士親王醫院呂志和臨床科學大樓 

研究负责人通讯地址:

中國香港沙田威爾士親王醫院呂志和臨床科學大樓 

Applicant address:

Department of Microbiology, 1/F LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT., Hong Kong SAR, China 

Study leader's address:

Department of Microbiology, 1/F LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT., Hong Kong SAR, China 

申请注册联系人邮政编码:

Applicant postcode:

000 

研究负责人邮政编码:

Study leader's postcode:

000 

申请人所在单位:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong 

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:

2017.659 

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:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-01 

伦理委员会联系人:

Ms. Jenny Ng 

Contact Name of the ethic committee:

Ms. Jenny Ng 

伦理委员会联系地址:

中國香港沙田威爾士親王醫院呂志和臨床科學大樓 

Contact Address of the ethic committee:

8/F, LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 35053935 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

crec@cuhk.edu.hk 

研究实施负责(组长)单位:

香港中文大學 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港沙田威爾士親王醫院呂志和臨床科學大樓 

Primary sponsor's address:

Department of Microbiology, 1/F LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT., Hong Kong SAR, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

香港中文大學 

Source(s) of funding:

The Chinese University of Hong Kong 

研究疾病:

乳腺癌 

Target disease:

Breast cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

Characterize and compare the structural and functional profile of gut microbiota between women with hormonal receptor-positive breast cancer and controls 

Objectives of Study:

Characterize and compare the structural and functional profile of gut microbiota between women with hormonal receptor-positive breast cancer and controls 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

No intervention of treatment 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1. Chinese female; 2. Aged greater than or equal to 18 years (no upper age limit); 3. Either: with a newly (within 3 months without surgical intervention other than biopsy) suspected benign or malignant breast lesion(s) for which tissue sample has been/will be taken pathological diagnosis (regardless of the results); OR: a bilateral mammogram / ultrasonic examination of the breast has been / will be performed within 3 months of enrollment (regardless of the results); 4. Willing to complete a questionnaire on medical history, life style and health information. 5. Willing to provide clinical findings and investigation results including pathology, radiography and ultrasonography reports related to the health status of breast. 6. Willing to donate a stool sample for this study (other optional samples include urine, blood and remaining breast tissue after completing pathological investigations). 7. Willing to provide a consent for study. 

Inclusion criteria

1. Chinese female; 2. Aged greater than or equal to 18 years (no upper age limit); 3. Either: with a newly (within 3 months without surgical intervention other than biopsy) suspected benign or malignant breast lesion(s) for which tissue sample has been/will be taken pathological diagnosis (regardless of the results); OR: a bilateral mammogram / ultrasonic examination of the breast has been / will be performed within 3 months of enrollment (regardless of the results); 4. Willing to complete a questionnaire on medical history, life style and health information. 5. Willing to provide clinical findings and investigation results including pathology, radiography and ultrasonography reports related to the health status of breast. 6. Willing to donate a stool sample for this study (other optional samples include urine, blood and remaining breast tissue after completing pathological investigations). 7. Willing to provide a consent for study. 

排除标准:

1. Had undergone surgical removal of part or whole breast tissue (other than biopsy); 2. Had received any treatment for malignant breast lesions including surgery, radiotherapy, chemotherapy or hormonal therapy; 3. History of any cancer (not include the current suspected/confirmed breast lesion); 4. Had received antibiotics with the last 3 weeks (can postpone stool collection to 3 weeks after completing antibiotic treatment); 5. History of inflammatory bowel diseases or diverticulitis; 6. History of gastric banding or bypass; 7. History of major gastric or intestinal surgery (not include endoscopy, biopsy, removal of polyps or haemorrhoids). 

Exclusion criteria:

1. Had undergone surgical removal of part or whole breast tissue (other than biopsy); 2. Had received any treatment for malignant breast lesions including surgery, radiotherapy, chemotherapy or hormonal therapy; 3. History of any cancer (not include the current suspected/confirmed breast lesion); 4. Had received antibiotics with the last 3 weeks (can postpone stool collection to 3 weeks after completing antibiotic treatment); 5. History of inflammatory bowel diseases or diverticulitis; 6. History of gastric banding or bypass; 7. History of major gastric or intestinal surgery (not include endoscopy, biopsy, removal of polyps or haemorrhoids). 

研究实施时间:

Study execute time:

From2018-04-10To 2019-01-31 

征募观察对象时间:

Recruiting time:

From2018-04-10To 2019-01-31 

干预措施:

Interventions:

组别:

Case group 1:

样本量:

100

Group:

Post-menopausal estrogen receptor-positive breast cancer

Sample size:

干预措施:

No

干预措施代码:

Intervention:

no

Intervention code:

组别:

Case group 2:

样本量:

100

Group:

Pre-menopausal estrogen receptor-positive breast cancer

Sample size:

干预措施:

No

干预措施代码:

Intervention:

no

Intervention code:

组别:

Control group 1:

样本量:

100

Group:

Pre-/post-menopausal estrogen receptor-negative breast cancer

Sample size:

干预措施:

干预措施代码:

Intervention:

Control group 2: Pre/post-menopausal non-malignant breast conditions

Intervention code:

组别:

Control group 3:

样本量:

100

Group:

Post-menopausal healthy controls (no abnormal breast pathology, normal mammogram or ultrasonography)

Sample size:

干预措施:

No

干预措施代码:

Intervention:

no

Intervention code:

组别:

Control group 4:

样本量:

100

Group:

Pre-menopausal healthy controls (no abnormal breast pathology, normal mammogram or ultrasonography)

Sample size:

干预措施:

No

干预措施代码:

Intervention:

no

Intervention code:

组别:

Control group 2:

样本量:

100

Group:

Pre/post-menopausal non-malignant breast conditions

Sample size:

干预措施:

No

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SR 

City:

Hong Kong 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

profile of gut microbiota in hormonal receptor-positive breast cancer and controls

指标类型:

主要指标 

Outcome:

profile of gut microbiota in hormonal receptor-positive breast cancer and controls

Type:

Primary indicator 

测量时间点:

cross-sectional at enrollment

测量方法:

sequencing and bioinformatics

Measure time point of outcome:

cross-sectional at enrollment

Measure method:

sequencing and bioinformatics

指标中文名:

Identify the correlations between gut and breast tissue microbiota among women with different subtypes of breast cancer or benign conditions.

指标类型:

次要指标 

Outcome:

Identify the correlations between gut and breast tissue microbiota among women with different subtypes of breast cancer or benign conditions.

Type:

Secondary indicator 

测量时间点:

cross-sectional at enrollment

测量方法:

sequencing and bioinformatics

Measure time point of outcome:

cross-sectional at enrollment

Measure method:

sequencing and bioinformatics

指标中文名:

Correlate gut microbiota with level of estrogens and estrogen metabolites in urine and blood, and with breast tissue microbiota.

指标类型:

次要指标 

Outcome:

Correlate gut microbiota with level of estrogens and estrogen metabolites in urine and blood, and with breast tissue microbiota.

Type:

Secondary indicator 

测量时间点:

cross-sectional at enrollment

测量方法:

sequencing and bioinformatics

Measure time point of outcome:

cross-sectional at enrollment

Measure method:

sequencing and bioinformatics

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

stool

组织:

Sample Name:

stool

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

标本中文名:

tissue

组织:

breast tissue

Sample Name:

tissue

Tissue:

breast tissue

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

标本中文名:

blood

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

标本中文名:

urine

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

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 years
最大 Max age 100 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):

observational study, no randomization

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

observational study, no randomization

盲法:

Blinding:

no

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

shared via institutional platforms

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

shared via institutional platforms

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:

Records of clinical, pathological, radiographic and ultrasonic findings and results of laboratory investigations related to the current breast health status will be collected for study analysis.

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

Records of clinical, pathological, radiographic and ultrasonic findings and results of laboratory investigations related to the current breast health status will be collected for study analysis.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-03-23
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