今天是:2019-05-24 星期五

基线,中期和化疗结束后的18F-FDG PET / CT图像在滤泡淋巴瘤患者中的预后价值
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注册号:

Registration number:

ChiCTR1900023183 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基线,中期和化疗结束后的18F-FDG PET / CT图像在滤泡淋巴瘤患者中的预后价值  

Public title:

Prognostic values of baseline, interim and end-of therapy 18F-FDG PET/CT scanning in patients with Follicular lymphoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基线,中期和化疗结束后的18F-FDG PET / CT图像在滤泡淋巴瘤患者中的预后价值 

Scientific title:

Prognostic values of baseline, interim and end-of therapy 18F-FDG PET/CT scanning in patients with Follicular lymphoma 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81601522);江苏省科技项目(BK20160348);江苏省青年医学人才项目(QNRC2016749) 

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:

周夜夜 

研究负责人:

邓胜明 

Applicant:

Yeye Zhou 

Study leader:

Shengming Deng 

申请注册联系人电话:

Applicant telephone:

+86 18506291758 

研究负责人电话:

Study leader's telephone:

+86 15051510189 

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:

zhouyeye23@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dshming@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:

苏州市十梓街188号 

研究负责人通讯地址:

苏州市十梓街188号 

Applicant address:

188 Shizi Street, Suzhou, Jiangsu, China  

Study leader's address:

188 Shizi Street, Suzhou, Jiangsu, 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:

苏州大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Soochow University  

是否获伦理委员会批准:

否 

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 

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:

苏州大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Soochow University  

研究实施负责(组长)单位地址:

苏州市十梓街188号 

Primary sponsor's address:

188 Shizi Street, Suzhou, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

苏州大学附属第一医院

具体地址:

苏州市十梓街188号

Institution
hospital:

The First Affiliated Hospital of Soochow University

Address:

188 Shizi Street, Suzhou

经费或物资来源:

国家自然科学基金(81601522);江苏省科技项目(BK20160348);江苏省青年医学人才项目(QNRC2016749) 

Source(s) of funding:

National Natural Science Foundation of China (No. 81601522), Natural Science Foundation of Jiangsu Province (No. BK20160348) and Medical Youth Talent Project of Jiangsu Province (No. QNRC2016749). 

研究疾病:

滤泡性淋巴瘤 

Target disease:

Follicular lymphoma 

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:

研究基线18F-FDG PET/CT中测量的半定量参数tMTV,TLG和SUVmax对滤泡性淋巴瘤患者的预后价值。探讨两种不同的标准(D-5PS和IHP)在中期及化疗结束后18F-FDG PET/CT中的预后价值。 

Objectives of Study:

To investigate the prognostic value of semi-quantitative parameters on baseline 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) in patients with Follicular lymphoma (FL), and to explore the prognostic value of interim and end-of treatment PET/CT using 2 different criteria: Deauville five-point scale (D-5PS) and International Harmonization Project criteria (IHP). 

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)经组织学证实,(3)患者行基线PET/CT (B-PET),或/和在2-4个化疗周期后行中期PET/CT(I-PET),或/和所有计划的一线治疗结束后行化疗结束后PET/CT(E-PET)。 

Inclusion criteria

(1) aged ≥ 18 years; (2) histologically confirmed; (3) patient undergone baseline PET/CT (B-PET), or /and interim PET/CT (I-PET) after 2-4 cycles of chemotherapy, or/and end-of treatment PET/CT (E-PET) after all planned first-line therapy.  

排除标准:

先前已知的其他恶性病史。 

Exclusion criteria:

The exclusion criteria were a previously known history of other malignance 

研究实施时间:

Study execute time:

From2019-05-21To 2019-06-12 

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):

病理检测

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):

hematological test

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):

18F-FDG PET/CT

Index test:

18F-FDG PET/CT

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)

病理证实为滤泡淋巴瘤的患者

例数:

Sample size:

84

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):

follicular lymphoma patients

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):

江苏省 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

苏州大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

最大标准摄取值

指标类型:

主要指标 

Outcome:

SUVmax

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢体积

指标类型:

主要指标 

Outcome:

MTV

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖酵解总量

指标类型:

主要指标 

Outcome:

TLG

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:

NA

组织:

Sample Name:

NA

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 25 years
最大 Max age 80 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):

NA

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

N/A

盲法:

未说明

Blinding:

Not stated

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

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

联系实验者公开

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

contact with the applicant

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:

word 和 excel

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

word and excel

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-15
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