Today is 2019-12-13

PDX model building and multi-omics screening of pancreatic cancer
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注册号:

Registration number:

ChiCTR1900027646 

最近更新日期:

Date of Last Refreshed on:

2019-11-23 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胰腺癌PDX模型建立与多组学筛查 

Public title:

PDX model building and multi-omics screening of pancreatic cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胰腺癌PDX模型建立与多组学筛查 

Scientific title:

PDX model building and multi-omics screening of pancreatic cancer 

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:

程科 

研究负责人:

彭兵 

Applicant:

KE CHENG 

Study leader:

BING PENG 

申请注册联系人电话:

Applicant telephone:

+86 13398175830 

研究负责人电话:

Study leader's telephone:

+86 18980601481 

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:

274179576@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

pengbing84@hotmail.com 

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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan 

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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2019年审(955)号 

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:

四川大学华西医院生物医学伦理委员会 

Name of the ethic committee:

Biomedical ethics committee of West China hospital of Sichuan university  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-11 

伦理委员会联系人:

史小媛 

Contact Name of the ethic committee:

Xiaoyuan Shi 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University  

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

四川大学学1.3.5工程项目 

Source(s) of funding:

1.3.5 project of Sichuan university 

研究疾病:

胰腺癌 

Target disease:

pancreatic cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

通过粪便菌群宏基因测序与粪便非靶向代谢组学联合分析,寻找胰腺癌组与健康组间的差异菌群与差异代谢物,探索胰腺癌发病与肠道微生物间的可能关系。根据结果建立诊断性Panel并在其他序列中验证。旨在了解肠道微生物对胰腺癌发病的影响,并且希望建立有效的胰腺癌发病预测模型,用于胰腺癌的早期诊断。 

Objectives of Study:

Through faecal flora acer for sequencing associated with waste not targeted metabolomic analysis, looking for pancreatic cancer group and healthy group differences flora and metabolites, explore the possible relationship between pancreatic cancer and gut microbes. According to the results to establish the diagnostic Panel and validation in the other sequences. Aims to understand the impact of gut microbes on pancreatic cancer, and hopes to establish an effective pancreatic cancer prediction model, is used for the early diagnosis of pancreatic cancer. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

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)经组织病理学和(或)细胞学检查确诊的胰腺癌,包括:1)EUS或CT引导下穿刺活组织检查;2)腹水脱落细胞学检查;3)腹腔镜或开腹手术下探查活组织检查; (2)胰腺癌病理类型为导管腺癌(包括腺鳞癌、胶样癌[黏液性非囊性癌]、肝样腺癌、髓样癌、印戒细胞癌、未分化癌、伴有破骨样巨细胞的未分化癌等特殊亚型),壶腹周围癌组病理类型包括除胰头癌外的壶腹周围组织恶性肿瘤(胆总管末端、十二指肠乳头等部位的腺癌)。 

Inclusion criteria

(1) the histopathology and (or) cytology diagnosis of pancreatic cancer, including: 1) the EUS or CT guided puncture biopsy; Fall off 2) ascites cytology; 3) probe under laparoscopy or laparotomy biopsy; (2) pancreatic cancer pathological types of ductal adenocarcinoma (including glands squamous carcinoma, mucinous carcinoma [] mucous sex of cystic carcinoma, liver samples, medullary carcinoma, adenocarcinoma, undifferentiated carcinoma, signet ring cell carcinoma with broken bone giant cell anaplastic carcinoma and other special subtype) and pathological types include around ampulla carcinoma group except the pancreatic head carcinoma of ampulla surrounding tissues malignant tumor (end of the common bile duct and duodenum papillary adenocarcinoma etc). 

排除标准:

1、肿瘤TNM分期处于III期或IV期或者一般情况极差的患者; 2、肠外营养或部分肠内营养患者; 3、长期酗酒者及严重肝肾疾病者; 4、已进行化疗或放疗患者; 5、已经证实与肠道微生物存在因果关联的状态或疾病患者(II型糖尿病、动脉粥样硬化症、肥胖[BMI>30]、肝硬化、结直肠癌、类风湿性关节炎); 6、可能影响肠道微生物种类及代谢的疾病患者(胆囊炎、阑尾炎、各种肠道炎症性疾病); 7、正在服用影响肠道微生物种类及代谢药物的患者(抗生素类药物、二甲双胍类药物、抗风湿药物以及其他可能影响药物); 8、大型胃肠道手术术后患者; 9、腹泻或便秘患者。 

Exclusion criteria:

1. tumor TNM staging in stage III or IV or generally poor patients; 2. parenteral nutrition or part of the patients with enteral nutrition; 3. chronic alcoholism and severe liver and kidney disease; 4. chemotherapy or radiotherapy patients; 5. have confirmed with the gut microbes causal correlation condition or disease patients (type II diabetes, sclerosis of arterial congee appearance, obesity (BMI > 30), liver cirrhosis, colorectal cancer, rheumatoid arthritis). 6. may affect the gut microbes species and metabolic disease, cholecystitis, appendicitis, various intestinal inflammatory diseases); 7. are taking affect gut microbes species and metabolism of drugs in patients with drugs (antibiotics, metformin, anti-rheumatism medicine and other may affect drug); 8. large gastrointestinal surgery patients; 9. diarrhea or constipation patients. 

研究实施时间:

Study execute time:

From2019-11-30To 2022-03-01 

干预措施:

Interventions:

组别:

胰腺癌组

样本量:

30

Group:

pancreatic cancer group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

组别:

壶腹周围癌组

样本量:

30

Group:

ampullary cancer

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

组别:

健康组

样本量:

30

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肠道菌群宏基因

指标类型:

主要指标 

Outcome:

gene

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢物

指标类型:

主要指标 

Outcome:

metabolites

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:

feces

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

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

N/A

盲法:

N/A

Blinding:

N/A

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):

实验记录

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

The experimental records

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:

CRF

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:

有/Yes

注册人:

Name of Registration:

 2019-11-22
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