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Cancer therapy and microbiota
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注册号:

Registration number:

ChiCTR1900021581 

最近更新日期:

Date of Last Refreshed on:

2019-02-28 

注册时间:

Date of Registration:

2019-02-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

微生物群與癌症治療 

Public title:

Cancer therapy and microbiota  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

癌症治療後口腔和腸道微生物群變化的觀察性研究 

Scientific title:

An observational study on the changes in oral and gut microbiota following cancer therapy 

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:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓1樓 

研究负责人通讯地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓1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:

2018.651 

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:

2019-01-08 

伦理委员会联系人:

Miss Envy Lee 

Contact Name of the ethic committee:

Miss Envy Lee 

伦理委员会联系地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓8樓 

Contact Address of the ethic committee:

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

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:

香港中文大學微生物學系 

Primary sponsor:

Department of Microbiology, The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓1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:

Study on malignant tumour 

Target disease:

Study on malignant tumour 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

Primary objective: 1. Delineate changes in gut and oral microbial community profiles of cancer therapy patients before and after therapy. Secondary objectives: 2. Correlate baseline gut and oral microbial community profiles with the origin of primary tumours; 3. Correlate changes in gut and oral microbial community profiles with the development of toxicity; 4. Compare gut and oral microbial community profiles between cancer patients and age-/sex-matched healthy controls (to be recruited under another study with ethics approval obtained). 

Objectives of Study:

Primary objective: 1. Delineate changes in gut and oral microbial community profiles of cancer therapy patients before and after therapy. Secondary objectives: 2. Correlate baseline gut and oral microbial community profiles with the origin of primary tumours; 3. Correlate changes in gut and oral microbial community profiles with the development of toxicity; 4. Compare gut and oral microbial community profiles between cancer patients and age-/sex-matched healthy controls (to be recruited under another study with ethics approval obtained). 

药物成份或治疗方案详述:

No treatment protocol to be evaluated in this study. 

Description for medicine or protocol of treatment in detail:

No treatment protocol to be evaluated in this study. 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. Chinese people aged 18 or above, no upper age limit; 3. Having newly diagnosed malignant tumour; 4. A new case referred to the Oncology Centre for management. 

Inclusion criteria

1. Chinese people aged 18 or above, no upper age limit; 3. Having newly diagnosed malignant tumour; 4. A new case referred to the Oncology Centre for management. 

排除标准:

1. Patients who have previously received cancer therapy; 2. Patients who will receive concurrent radiotherapy; 3. Patients with conditions rendering them incapable to answer questionnaires or provide oral and stool samples; 4. Subjects who are unable to give consent. 

Exclusion criteria:

1. Patients who have previously received cancer therapy; 2. Patients who will receive concurrent radiotherapy; 3. Patients with conditions rendering them incapable to answer questionnaires or provide oral and stool samples; 4. Subjects who are unable to give consent. 

研究实施时间:

Study execute time:

From2019-03-05To 2021-03-04 

征募观察对象时间:

Recruiting time:

From2019-03-05To 2021-03-04 

干预措施:

Interventions:

组别:

Group A

样本量:

100

Group:

A

Sample size:

干预措施:

Chemotherapy

干预措施代码:

Intervention:

Chemotherapy

Intervention code:

组别:

Group B

样本量:

50

Group:

B

Sample size:

干预措施:

Immunotherapy

干预措施代码:

Intervention:

Immunotherapy

Intervention code:

组别:

Group C

样本量:

150

Group:

C

Sample size:

干预措施:

No anti-cancer therapy

干预措施代码:

Intervention:

No anti-cancer therapy

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 SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong  

单位级别:

大学 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

Changes in gut and oral microbial community profiles measured by 16s and metagenomics sequencing before and after cancer therapy.

指标类型:

主要指标 

Outcome:

Changes in gut and oral microbial community profiles measured by 16s and metagenomics sequencing before and after cancer therapy.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Correlation of gut and oral microbial community profiles measured by 16s and metagenomics sequencing with respect to tumour type and toxicity.

指标类型:

次要指标 

Outcome:

Correlation of gut and oral microbial community profiles measured by 16s and metagenomics sequencing with respect to tumour type and toxicity.

Type:

Secondary 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:

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:

oral rinse

组织:

Sample Name:

oral rinse

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:

saliva

组织:

Sample Name:

saliva

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:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

盲法:

Open

Blinding:

Open

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:

Collection of information: 1. A standard proforma will be used to collect baseline information including demographics, tumour diagnosis, tumour stage and routine laboratory investigations at enrolment and at follow-up. 2. A standard questionnaire will be used to collect information concerning the 3 days prior to stool sample collection. 3. Medical information of subjects related to patients’ current illnesses will be retrieved from the Clinical Management System of the Hospital Authority. Data collection and management: Manual filling of clinical information and electronic data capture

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

Collection of information: 1. A standard proforma will be used to collect baseline information including demographics, tumour diagnosis, tumour stage and routine laboratory investigations at enrollment and at follow-up. 2. A standard questionnaire will be used to collect information concerning the 3 days prior to stool sample collection. 3. Medical information of subjects related to patients’ current illnesses will be retrieved from the Clinical Management System of the Hospital Authority. Data collection and management: Manual filling of clinical information and electronic data capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-02-28
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