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此为补注册,需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册 应用大病理切片评估胶质瘤的浸润范围及其在放疗临床靶区勾画中的应用
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注册号:

Registration number:

ChiCTR2100049376 

最近更新日期:

Date of Last Refreshed on:

2022-04-05 

注册时间:

Date of Registration:

1990-01-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

此为补注册,需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册 应用大病理切片评估胶质瘤的浸润范围及其在放疗临床靶区勾画中的应用 

Public title:

Prospective evaluation of microscopic tumor extension in glioma using macropathology: Determination of optimal clinical target volume margins for precise radiotherapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用大病理切片评估胶质瘤的浸润范围及其在放疗临床靶区勾画中的应用 

Scientific title:

Prospective evaluation of microscopic tumor extension in glioma using macropathology: Determination of optimal clinical target volume margins for precise radiotherapy 

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:

胡漫 

研究负责人:

胡漫 

Applicant:

Man Hu 

Study leader:

Man Hu 

申请注册联系人电话:

Applicant telephone:

+86 15762961001 

研究负责人电话:

Study leader's telephone:

+86 15762961001 

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:

human5770@163.com 

研究负责人电子邮件:

Study leader's E-mail:

human5770@163.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:

山东省济南市槐荫区济兖路440号 

研究负责人通讯地址:

山东省济南市槐荫区济兖路440号 

Applicant address:

440 Jiyan Road, Huaiyin District, Ji'nan, Shandong, China 

Study leader's address:

440 Jiyan Road, Huaiyin District, Ji'nan, Shandong, China 

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:

山东省肿瘤医院 

Applicant's institution:

Shandong Cancer 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:

SDZLEC2019-110-22 

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:

山东省肿瘤防治研究院伦理委员会 

Name of the ethic committee:

Shandong Cancer Hospital and Institute Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-12-10 

伦理委员会联系人:

李朝伟 

Contact Name of the ethic committee:

Chaowei Li 

伦理委员会联系地址:

山东省济南市槐荫区济兖路440号 

Contact Address of the ethic committee:

440 Jiyan Road, Huaiyin District, Ji'nan, Shandong, 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:

山东省肿瘤医院 

Primary sponsor:

Shandong Cancer Hospital  

研究实施负责(组长)单位地址:

山东省济南市槐荫区济兖路440号 

Primary sponsor's address:

440 Jiyan Road, Huaiyin District, Ji'nan, Shandong, 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):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong

City:

单位(医院):

山东省肿瘤医院

具体地址:

山东省济南市槐荫区济兖路440号

Institution
hospital:

Shandong Cancer Hospital

Address:

440 Jiyan Road, Huaiyin District, Ji'nan

经费或物资来源:

国家重点研发计划项目(No. 2018YFE0114100) 

Source(s) of funding:

National Key Research and Development Program of China (No. 2018YFE0114100) 

研究疾病:

神经胶质瘤 

Target disease:

Glioma 

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:

其它 

Study phase:

N/A 

研究目的:

本研究对来源于胶质瘤患者的完整大病理切片进行了分析,评估胶质瘤细胞的微浸润范围(microscopic extension, ME),为准确定义胶质瘤患者的放疗临床靶区(clinical target volume, CTV)提供依据 

Objectives of Study:

In this study, we aimed to perform a complete macropathologic analysis examining microscopic tumor extension (ME) to more accurately determine the CTV in glioma 

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)年龄≥18岁; (2)术前KPS评分≥80分; (3)肿瘤位于大脑非功能区域; (4)肿瘤生长位置允许超全切除并且切除边缘包括周围脑正常组织(距离肿瘤边界2cm-3cm)  

Inclusion criteria

(a) patients aged 18 years or older; (b) preoperative Karnofsky Performance Status ≥ 80; (c) tumor grew in non-functional areas; (d) tumor location allowing a supratotal resection and resection margins that 2 cm and 3 cm far from the tumor border (defined as the enhancing border of tumor on T1-weighted MR images; for non-enhancing gliomas, tumor border was defined as the border of hyperintensity signal seen on T2-weighted MR images) 

排除标准:

(a)既往脑肿瘤史、颅脑手术史、颅脑放疗史、化疗史以及磁共振成像禁忌症; (b)多灶性病变 

Exclusion criteria:

(a) a history of a previous brain tumor, cranial surgery, radiotherapy, chemotherapy, or contraindication for MR imaging; (b) multifocal lesions 

研究实施时间:

Study execute time:

From2016-02-01To 2020-11-04 

征募观察对象时间:

Recruiting time:

From2016-02-01To 2020-11-04 

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):

病理科诊断报告

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):

Diagnostic report of pathology department of Shandong Cancer Hospital

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):

Siemens Prisma 3.0T 磁共振扫描仪及配套正交头部64通道专用线圈

Index test:

Siemens Prisma 3.0T Magnetic Resonance Scanner with 64-channel dedicated coil for quadrature head

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)

术后病理报告为脑神经胶质瘤的患者

例数:

Sample size:

38

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):

Postoperative pathology report is a patient with cerebral glioma

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):

山东省 

市(区县):

济南市 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东省肿瘤医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shandong Cancer Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

微浸润范围

指标类型:

主要指标 

Outcome:

Microscopic extension

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄,性别,肿瘤级别,肿瘤体积,水肿体积,肿瘤位置,MGMT,IDH,1p/19q

指标类型:

次要指标 

Outcome:

age, gender, tumor grade, tumor size, PTBE size, tumor location, MGMT,IDH,1p/19q

Type:

Secondary 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:

颅脑肿瘤组织

组织:

颅脑

Sample Name:

Brain tumor tissue

Tissue:

Brain

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

N/A

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

N/A

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

是Yes

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):

文章见刊后6个月内,利用临床试验公共管理平台(www.medresman.org)

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

The article uses the Clinical Trial Public Management Platform (www.medresman.org) within 6 months of the publication

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:

病历记录表记录入组病人,影像原始数据用移动硬盘保留并备份,文章见刊后上传至ResMan

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

The medical record record is recorded into the group of patients, and the original image data is retained and backed up by the mobile hard disk. The article is uploaded to ResMan after publication

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 1990-01-01
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