ChiCTR2100050048 版本V1.0 版本创建时间2021/08/16 05:01:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100050048 

最近更新日期：

Date of Last Refreshed on：

2021-08-16 05:00:27 

注册时间：

Date of Registration：

2021-08-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Shon Shmushkevich: this form is not completed, lack the date of recruitment

Public title：

Sex Differences in Primary Malignant Cardiac Tumors: A Multi-Institutional Study from National Cancer Database

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Sex Differences in Primary Malignant Cardiac Tumors: A Multi-Institutional Study from National Cancer Database

Scientific title：

Sex Differences in Primary Malignant Cardiac Tumors: A Multi-Institutional Study from National Cancer Database

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：

Dr. Mohamed Rahouma 

研究负责人：

Dr. Mohamed Rahouma 

Applicant：

Shon Shmushkevich 

Study leader：

Dr. Mohamed Rahouma 

申请注册联系人电话：

Applicant telephone：

+1 718 844 0655

研究负责人电话：

Study leader's telephone：

+1 201 208 4203

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：

shonshmushkevich@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

mhmdrahouma@gmail.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：

525 East 68th St, Box 110, New York, NY 10065

研究负责人通讯地址：

mhmdrahouma@gmail.com

Applicant address：

525 East 68th St, Box 110, New York, NY 10065

Study leader's address：

525 East 68th St, Box 110, New York, NY 10065

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：

美国纽约威尔康乃尔医学院

Applicant's institution：

Department of Cardiothoracic Surgery, Weill Cornell Medicine

研究负责人所在单位：

美国纽约威尔康乃尔医学院

Affiliation of the Leader：

Department of Cardiothoracic Surgery, Weill Cornell Medicine

是否获伦理委员会批准：

否/No

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

美国纽约威尔康乃尔医学院

Primary sponsor：

Department of Cardiothoracic Surgery, Weill Cornell Medicine

研究实施负责（组长）单位地址：

525 East 68th St, Box 110, New York, NY 10065

Primary sponsor's address：

525 East 68th St, Box 110, New York, NY 10065

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

美国

省(直辖市)：

纽约

市(区县)：

Country：

United States

Province：

New York

City：

单位(医院)：

威尔康乃尔医学院

具体地址：

525 East 68th St, Box 110, New York, NY 10065

Institution
hospital：

Weill Cornell Medicine

Address：

525 East 68th St, Box 110, New York, NY 10065

经费或物资来源：

Weill Cornell Medicine

Source(s) of funding：

Weill Cornell Medicine

Target disease：

Primary Malignant Cardiac Tumors

Target disease code：

研究类型：

流行病学研究

Study type：

Epidemilogical research

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

Despite the significant clinical importance of sex among factors affecting cancer progression and survival, it remains one of the least studied factors. Primary malignant cardiac tumors (PMCTs) are rare neoplasms with dismal outcomes. Despite the increased emphasis on personalized medicine, still few studies report sex distinction outcomes. Therefore, we sought to examine these differences in relation to PMCTs using a national dataset.  

Objectives of Study：

Despite the significant clinical importance of sex among factors affecting cancer progression and survival, it remains one of the least studied factors. Primary malignant cardiac tumors (PMCTs) are rare neoplasms with dismal outcomes. Despite the increased emphasis on personalized medicine, still few studies report sex distinction outcomes. Therefore, we sought to examine these differences in relation to PMCTs using a national dataset.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Primary Malignant Cardiac Tumors PMCTs

Inclusion criteria

Primary Malignant Cardiac Tumors PMCTs

排除标准：

All tumors with sequence of malignant neoplasms of more than 1 over the lifetime of the patient and those with missing survival time or status were excluded.

Exclusion criteria：

All tumors with sequence of malignant neoplasms of more than 1 over the lifetime of the patient and those with missing survival time or status were excluded.

研究实施时间：

Study execute time：

从 From 2021-08-02 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-08-02 00:00:00 至 To 2021-08-30 00:00:00  

干预措施：

Interventions：

组别：

PMTcs

样本量：

1000

Group：

PMTcs

Sample size：

干预措施：

N/A

干预措施代码：

Intervention：

N/a

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

Worldwide 

Province：

Worldwide 

City：

 

单位(医院)：

 

单位级别：

 

Institution
hospital：

Worldwide

Level of the institution：

Worldwide

测量指标：

Outcomes：

指标中文名：

Mortality

指标类型：

主要指标

Outcome：

Mortality

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：

组织：

Sample Name：

PMCT

Tissue：

N/a

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

N/a

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 0 岁 years
最大 Max age 120 岁 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）：

The 2004-2018 National Cancer Database (NCDB) will be queried for patients with PMCTs.

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

The 2004-2018 National Cancer Database (NCDB) will be queried for patients with PMCTs.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

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）：

https://www.facs.org/quality-programs/cancer/ncdb/publicaccess

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

https://www.facs.org/quality-programs/cancer/ncdb/publicaccess

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：

The 2004-2018 National Cancer Database (NCDB) will be queried for patients with PMCTs. The following variables will be assessed: age, sex, race, insurance status, median income quartile, metropolitan/urban/rural counties, education (expressed as no high school graduate quartile; that provides a measure of the number of adults age 25 or older in the patient's zip code who did not graduate from high school, and is categorized as equally proportioned quartiles among all US zip codes), great circle distance, which is the distance in miles between the patient's residence and the hospital that reported the case, Charlson/Deyo comorbidity condition index (CDCC, categorized as (0 or 1 vs 2 or 3)), year of diagnosis, histology, tumor size, analytic stage, facility type (categorized as 1-Academic/integrated facilities (that included A) Community Cancer Program and B) Comprehensive Community Cancer Program) or 2- community facilities (that included A) Academic/Research Program and B) Integrated Network Cancer Program)), different treatment patterns such as surgery, radiotherapy and chemotherapy, 30-days mortality and late mortality.

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

The 2004-2018 National Cancer Database (NCDB) will be queried for patients with PMCTs. The following variables will be assessed: age, sex, race, insurance status, median income quartile, metropolitan/urban/rural counties, education (expressed as no high school graduate quartile; that provides a measure of the number of adults age 25 or older in the patient's zip code who did not graduate from high school, and is categorized as equally proportioned quartiles among all US zip codes), great circle distance, which is the distance in miles between the patient's residence and the hospital that reported the case, Charlson/Deyo comorbidity condition index (CDCC, categorized as (0 or 1 vs 2 or 3)), year of diagnosis, histology, tumor size, analytic stage, facility type (categorized as 1-Academic/integrated facilities (that included A) Community Cancer Program and B) Comprehensive Community Cancer Program) or 2- community facilities (that included A) Academic/Research Program and B) Integrated Network Cancer Program)), different treatment patterns such as surgery, radiotherapy and chemotherapy, 30-days mortality and late mortality.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-16 05:00:27