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乳腺癌治疗后发生肺癌的分子机制及影响因素分析
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注册号:

Registration number:

ChiCTR2000040165 

最近更新日期:

Date of Last Refreshed on:

2020-11-23 

注册时间:

Date of Registration:

2020-11-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

乳腺癌治疗后发生肺癌的分子机制及影响因素分析 

Public title:

Analysis of molecular mechanisms and influencing factors of lung cancer after breast cancer treatment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

乳腺、肺双原发癌的临床病理及分子机制研究 

Scientific title:

Study on clinicopathological and molecular mechanisms of double primary carcinoma of breast and lung 

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:

王彦 

研究负责人:

车国卫 

Applicant:

Yan Wang 

Study leader:

Guowei Che 

申请注册联系人电话:

Applicant telephone:

18280022770 

研究负责人电话:

Study leader's telephone:

18980601890 

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:

wangyanxw@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hxxiongwai@126.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:

成都市人民南路三段17号 

研究负责人通讯地址:

成都市国学巷37号 

Applicant address:

No. 17, Section 3, Renmin South Road, Chengdu 

Study leader's address:

Guoxue Alley 37, Chengdu 

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 of 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:

2020.250 

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审查委员会 

Name of the ethic committee:

Biomedical Ethics Review Committee of West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-01 

伦理委员会联系人:

邓绍林 

Contact Name of the ethic committee:

Shaolin Deng 

伦理委员会联系地址:

成都市四川大学华西校区老八教 

Contact Address of the ethic committee:

West China Campus, Sichuan University, Chengdu 

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 of Sichuan University 

研究实施负责(组长)单位地址:

成都国学巷37号 

Primary sponsor's address:

Guoxue Alley 37, Chengdu 

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):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都市国学巷37号

Institution
hospital:

West China Hospital of Sichuan Universit

Address:

Guoxue Alley 37, Chengdu

经费或物资来源:

四川省科技厅重点项目(2020YFS0252) 

Source(s) of funding:

Key Project of Sichuan Provincial Department of Science and Technology (2020YFS0252) 

研究疾病:

乳腺癌、肺癌 

Target disease:

breast cancer and lung 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:

探索性研究/预试验 

Study phase:

研究目的:

拟从基因分子表达层面探究与乳腺癌治疗后发生肺癌相关的分子机制并分析其影响因素,以期帮助评估乳腺癌患者发生肺癌的风险、制定适宜的治疗和随访策略 

Objectives of Study:

We intend to explore the molecular mechanism related to the occurrence of lung cancer after breast cancer treatment from the level of gene molecular expression and analyze its influencing factors, in order to help assess the risk of lung cancer in breast cancer patients and formulate appropriate treatment and follow-up strategies. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

①、病理学确诊且接受手术治疗(改良根治术、保乳手术+前哨淋巴结活检、乳房单纯切除+前哨淋巴结活检等 非姑息性手术方式) 的女性乳腺癌患者; ②、年龄 18-80 周岁; ③、乳腺癌手术 6 个月后发现肺腺癌且接受肺部肿瘤切除术; ④、保留有足够的肺癌、乳腺癌及癌旁标本供 WES 检测; ⑤、临床病理及随访资料完整; ⑥、同意使用标本进行基因测序者 

Inclusion criteria

①. Female breast cancer patients with pathological diagnosis and surgical treatment (modified radical mastectomy, breast-conserving surgery + sentinel lymph node biopsy, simple mastectomy + sentinel lymph node biopsy, etc. Non-palliative surgery) ; ②, age 18-80 years old; ③Pulmonary adenocarcinoma was discovered 6 months after breast cancer surgery and received lung tumor resection; ④. Keep enough lung cancer, breast cancer and adjacent specimens for WES testing; ⑤ Complete clinical pathology and follow-up data; ⑥ Those who agree to use specimens for gene sequencing 

排除标准:

①、合并其它部位恶性肿瘤或恶性疾病; ②、晚期乳腺癌 

Exclusion criteria:

① Combined with other malignant tumors or malignant diseases; ② Advanced breast cancer 

研究实施时间:

Study execute time:

From2021-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2021-01-01To 2021-05-31 

干预措施:

Interventions:

组别:

双原发癌组

样本量:

50

Group:

Double primary cancer group

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

单原发肺癌组

样本量:

50

Group:

Single primary lung cancer group

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

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):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital of Sichuan Universit  

Level of the institution:

3A grade 

测量指标:

Outcomes:

指标中文名:

体细胞突变

指标类型:

主要指标 

Outcome:

Somatic mutation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

mRNA表达

指标类型:

主要指标 

Outcome:

mRNA expression

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:

肺癌及癌旁正常组织

组织:

Sample Name:

Lung cancer and adjacent normal tissues

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 18 years
最大 Max age 80 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):

本研究为非随机对照试验

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

This study is a non-randomized controlled trial

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

TCGA数据库,https://portal.gdc.cancer.gov/

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

TCGA database,https://portal.gdc.cancer.gov/

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:

数据收集:每位入组患者在取得标本当天需完善CRF表 管理:待病理结果出来后及时将数据录入至ResMan系统

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

Data collection: Each enrolled patient needs to complete the CRF form on the day the specimen is obtained. Management: After the pathological results come out, enter the data into the ResMan system in time.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-23
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