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ANALYSIS OF PROGNOSTIC FACTORS IN SOFT TISSUE SARCOMA: CANCER REGISTRY FROM A SINGLE TERTIARY HOSPITAL IN INDONESIA
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注册号：

Registration number：

 ChiCTR2000033799 

最近更新日期：

Date of Last Refreshed on：

 2020-06-13 11:15:35 

注册时间：

Date of Registration：

 2020-06-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

ANALYSIS OF PROGNOSTIC FACTORS IN SOFT TISSUE SARCOMA: CANCER REGISTRY FROM A SINGLE TERTIARY HOSPITAL IN INDONESIA

Public title：

ANALYSIS OF PROGNOSTIC FACTORS IN SOFT TISSUE SARCOMA: CANCER REGISTRY FROM A SINGLE TERTIARY HOSPITAL IN INDONESIA

注册题目简写：

English Acronym：

研究课题的正式科学名称：

ANALYSIS OF PROGNOSTIC FACTORS IN SOFT TISSUE SARCOMA: CANCER REGISTRY FROM A SINGLE TERTIARY HOSPITAL IN INDONESIA

Scientific title：

ANALYSIS OF PROGNOSTIC FACTORS IN SOFT TISSUE SARCOMA: CANCER REGISTRY FROM A SINGLE TERTIARY HOSPITAL IN INDONESIA

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：

Adhinanda Gema Wahyudiputra, MD 

研究负责人：

Ferdiansyah 

Applicant：

Adhinanda Gema Wahyudiputra, MD 

Study leader：

Ferdiansyah 

申请注册联系人电话：

Applicant telephone：

 +62 8 7853057635

研究负责人电话：

Study leader's
telephone：

+62 8 11320635

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：

 adhinandagemamd@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 ferdyortho@yahoo.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：

Departemen Orthopaedi dan Traumatologi, RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

研究负责人通讯地址：

Departemen Orthopaedi dan Traumatologi, RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

Applicant address：

Departemen Orthopaedi dan Traumatologi, RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

Study leader's address：

Departemen Orthopaedi dan Traumatologi, RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

申请注册联系人邮政编码：

Applicant postcode：

 60286

研究负责人邮政编码：

Study leader's postcode：

 60286

申请人所在单位：

印度尼西亚泗水Dr. Soetomo总医院

Applicant's institution：

Resident, Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Airlangga/Dr. Soetomo General Hospital

研究负责人所在单位：

印度尼西亚泗水Dr. Soetomo总医院

Affiliation of the Leader：

Staff, Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Airlangga/Dr. Soetomo General Hospital

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：

 1314 / KEPK / VII / 2019

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：

Ethic Committee of Dr. Soetomo General Hospital, Surabaya, Indonesia

Name of the ethic committee：

Ethic Committee of Dr. Soetomo General Hospital, Surabaya, Indonesia

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-07-20 00:00:00

伦理委员会联系人：

Sekreatariat CRU RSUD Dr. Soetomo

Contact Name of the ethic committee：

Sekreatariat CRU RSUD Dr. Soetomo

伦理委员会联系地址：

RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

Contact Address of the ethic committee：

RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +62 03 15501164

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 cru.rsds1@gmail.com

研究实施负责（组长）单位：

Dr. Soetomo General Hospital

Primary sponsor：

Dr. Soetomo General Hospital

研究实施负责（组长）单位地址：

RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

Primary sponsor's address：

RSUD Dr. Soetomo/FK Unair, Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur, Indonesia

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

软组织肉瘤  

Target disease：

Soft Tissue Sarcoma

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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

To investigate and analyze the prognostic factors affecting survival, metastasis, and recurrence in patients with Soft Tissue Sarcoma  

Objectives of Study：

To investigate and analyze the prognostic factors affecting survival, metastasis, and recurrence in patients with Soft Tissue Sarcoma

药物成份或治疗方案详述：

This is a retrospective study. Between January 2012 to December 2018, 106 patients with a diagnosis of STS at Dr. Soetomo General Academic Hospital, a tertiary hospital in Indonesia, were recorded. All patients were registered in the musculoskeletal tumor registry. This registry collects patients' demographic data; preoperative, intraoperative, and postoperative data that include laboratory, radiological, and histopathological examination; treatment protocol; and postoperative follow-up including any complication or mortalities that may occur. The diagnosis and treatment protocols of STS in all patients were discussed and decided in a Clinico-pathological Conference (CPC) between pathologists, radiologists, oncologists, and orthopaedic surgeons. 

Description for medicine or protocol of treatment in detail：

This is a retrospective study. Between January 2012 to December 2018, 106 patients with a diagnosis of STS at Dr. Soetomo General Academic Hospital, a tertiary hospital in Indonesia, were recorded. All patients were registered in the musculoskeletal tumor registry. This registry collects patients' demographic data; preoperative, intraoperative, and postoperative data that include laboratory, radiological, and histopathological examination; treatment protocol; and postoperative follow-up including any complication or mortalities that may occur. The diagnosis and treatment protocols of STS in all patients were discussed and decided in a Clinico-pathological Conference (CPC) between pathologists, radiologists, oncologists, and orthopaedic surgeons. 

纳入标准：

Inclusion criteria

排除标准：

Patients with incomplete registry, failure to comply with treatment and follow-up protocol, and metastasis prior to treatment

Exclusion criteria：

Patients with incomplete registry, failure to comply with treatment and follow-up protocol, and metastasis prior to treatment

研究实施时间：

Study execute time：

从 From 2019-07-20 00:00:00至 To 2020-07-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-07-20 00:00:00 至 To 2020-07-20 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 106

Group：

Case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度尼西亚

省(直辖市)：

 东爪哇 

市(区县)：

 泗水 

Country：

Indonesia

Province：

East Java

City：

Surabaya

单位(医院)：

 Dr. Soetomo General Hospital 

单位级别：

 Tertiary-Academic Hospital 

Institution
hospital：

Dr. Soetomo General Hospital

Level of the institution：

Tertiary-Academic Hospital

测量指标：

Outcomes：

指标中文名：

Survival Rate

指标类型：

主要指标

Outcome：

Survival Rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Recurrent Rate

指标类型：

主要指标

Outcome：

Recurrent Rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Metastasis Rate

指标类型：

主要指标

Outcome：

Metastasis Rate

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 2 岁 years
最大 Max age 87 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）：

N/A

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

None

是否共享原始数据：

IPD sharing

否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）：

The IPD may be shared after study was finished.

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

The IPD may be shared after study was finished.

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：

Not yet

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

Not yet

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-06-13 11:15:35
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