今天是:2019-11-21 星期四

一项多中心、开放性、非随机和观察性的肉瘤基因变异的真实世界研究
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注册号:

Registration number:

ChiCTR1900025163 

最近更新日期:

Date of Last Refreshed on:

2019-08-15 

注册时间:

Date of Registration:

2019-08-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项多中心、开放性、非随机和观察性的肉瘤基因变异的真实世界研究 

Public title:

Genomic profiling analysis of clinical sarcomas: a multicenter, non-randomized, open and authentic study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项多中心、开放性、非随机和观察性的肉瘤基因变异的真实世界研究 

Scientific title:

Genomic profiling analysis of clinical sarcomas: a multicenter, non-randomized, open and authentic study 

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:

谢显彪 

研究负责人:

沈靖南 

Applicant:

Xianbiao Xie 

Study leader:

Jingnan Shen 

申请注册联系人电话:

Applicant telephone:

+86 13760645862 

研究负责人电话:

Study leader's telephone:

+86 13609715296 

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:

biao_zairen@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shenjn@mail.sysu.edu.cn 

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:

广州市越秀区中山二路58号 

研究负责人通讯地址:

广州市越秀区中山二路58号 

Applicant address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou 

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:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Sun Yat-Sen 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:

伦审【2018】249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:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

ICE for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-26 

伦理委员会联系人:

颜楚荣 

Contact Name of the ethic committee:

Churong Yan 

伦理委员会联系地址:

广州市越秀区中山二路58号 

Contact Address of the ethic committee:

58 Second Zhongshan Road, Yuexiu District, Guangzhou 

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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市越秀区中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第一医院

具体地址:

越秀区中山二路58号

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University

Address:

58 Second Zhongshan Road, Yuexiu District

经费或物资来源:

无经费 

Source(s) of funding:

No funds 

研究疾病:

肉瘤 

Target disease:

Sarcoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.从分子病理层面,观察NGS 对肉瘤病理诊断及鉴别诊断的价值; 2.分析与中国人群肉瘤发生发展相关的基因变异,绘制中国人群主要肉瘤类型的基因变异图谱; 3.探索肉瘤患者后续治疗(治疗方式包括但不限于靶向治疗、免疫治疗和化疗)的有效率(ORR)、无疾病进展期(PFS)和总生存期(OS)。 

Objectives of Study:

1. To evaluate the value of NGS in assistant pathological diagnosis of sarcoma at the molecular pathological level; 2. To analyze the genetic variations related to the occurrence and development of sarcoma in Chinese population, and to map the genetic profiling of major sarcoma types in Chinese population; 3. To explore the efficacy (ORR), disease-free progression (PFS) and overall survival (OS) of follow-up therapy (including but not limited to targeted therapy, immunotherapy and chemotherapy) for sarcoma patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.≥1 岁,性别不限; 2.诊断或疑似:骨肉瘤、脂肪肉瘤、软骨肉瘤、纤维肉瘤、尤文肉瘤家族肿瘤、滑膜肉瘤、平滑肌肉瘤、其他肉瘤(恶性外周神经鞘膜瘤、腺泡状软组织肉瘤、横纹肌肉瘤、透明细胞肉瘤、韧带样纤维瘤等); 3.至少一个可测量病灶(RECIST v1.1); 4.功能状态评分大于等于50%,对于年龄>16 岁的患者使用Karnofsky标准,对于≤16 岁的患者使用Lansky 标准; 5.受试者自愿参加研究并签署知情同意书。 

Inclusion criteria

1. Above 1 year old, gender is not limited; 2. Patients have been diagnosed or suspected with osteosarcoma, liposarcoma, chondrosarcoma, fibrosarcoma, Ewing's sarcoma family tumors, synovial sarcoma, leiomyosarcoma, and other sarcomas (malignant peripheral neurilemmoma, alveolar soft tissue sarcoma, rhabdomyosarcoma, hyaline cell sarcoma, ligamentous fibroma, etc.); 3. At least one measurable lesion (RECIST v1.1); 4. The score of functional status was more than or equal to 50%. Karnofsky criterion was used for patients over 16 years old and Lansky criterion was used for patients under 16 years old; 5. Subjects volunteered to participate in the study and signed the informed consent. 

排除标准:

1.CT/MRI 肿瘤边界不清,无可测量病灶(RECIST v1.1); 2.患者同时存在多处原发肿瘤; 3.存在药物滥用;或任何可能影响研究、患者依从性不稳定、甚至可能危及患者安全的医疗、心理或社会状况; 4.同时参与另一项对本次研究结果有影响的临床研究; 5.综合评估,研究者认为不适合参与本次研究的患者。 

Exclusion criteria:

1. CT/MRI Tumors with unclear margins and no measurable lesions; 2. The patients had multiple primary tumors at the same time; 3. Drug abuse; or any medical, psychological or social condition that may affect research, unstable patient compliance, or even endanger patient safety; 4. Participate in another clinical study that has an impact on the results of this study; 5. In a comprehensive assessment, the researchers did not consider it suitable for the patients who participated in this study. 

研究实施时间:

Study execute time:

From2018-10-26To 2021-12-31 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

病理诊断

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Pathologic diagnosis

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

Genomic profiling analysis by NGS (高通量二代测序)

Index test:

Genomic profiling analysis by NGS

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

诊断或疑似骨肉瘤、脂肪肉瘤、软骨肉瘤、纤维肉瘤、尤文肉瘤家族肿瘤、滑膜肉瘤、平滑肌肉瘤、其他肉瘤(恶性外周神经鞘膜瘤、腺泡状软组织肉瘤、横纹肌肉瘤、透明细胞肉瘤、韧带样纤维瘤等)患者

例数:

Sample size:

1000

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients have been diagnosed or suspected with osteosarcoma, liposarcoma, chondrosarcoma, fibrosarcoma, Ewing's sarcoma family tumors, synovial sarcoma, leiomyosarcoma, and other sarcomas (malignant peripheral neurilemmoma, alveolar soft tissue sarcoma, rhabdomyosarcoma, hyaline cell sarcoma, ligamentous fibroma, etc.)

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

高通量二代测序在中国肉瘤病理辅助诊断中的指导意义

指标类型:

主要指标 

Outcome:

The guiding Significance of NGS in Pathological Assisted Diagnosis of Sarcoma in China

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中国人群主要肉瘤类型的基因变异图谱

指标类型:

主要指标 

Outcome:

The gene profiling of major Sarcoma types in Chinese Population

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:

静脉血

组织:

肿瘤组织

Sample Name:

venous blood

Tissue:

Tumor 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 70 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:

N/A

Blinding:

N/A

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):

至本医疗土拨鼠博士APP

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

OrigiMed Dr. Groundhog APP

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:

至本医疗土拨鼠博士APP及科研宝EDC系统

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

OrigiMed Dr. Groundhog APP and Crabyter EDC system

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-08-15
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