Today is 2019-08-22

Prospective Cohort Study of the Radiologic Heterogeneity Between Lesions Detected by Nuclear Imaging in Castration Resistant Prostate Cancer (CRPC) Patients With Germline Mutation in DNA-repair Genes
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注册号:

Registration number:

ChiCTR1900022682 

最近更新日期:

Date of Last Refreshed on:

2019-04-21 

注册时间:

Date of Registration:

2019-04-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评价核医学影像对具有DNA修复基因胚系突变的去势抵抗性前列腺癌病灶检出率及病灶间异质性的前瞻性队列研究 

Public title:

Prospective Cohort Study of the Radiologic Heterogeneity Between Lesions Detected by Nuclear Imaging in Castration Resistant Prostate Cancer (CRPC) Patients With Germline Mutation in DNA-repair Genes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项评价核医学影像对具有DNA修复基因胚系突变的去势抵抗性前列腺癌病灶检出率及病灶间异质性的前瞻性队列研究 

Scientific title:

Prospective Cohort Study of the Radiologic Heterogeneity Between Lesions Detected by Nuclear Imaging in Castration Resistant Prostate Cancer (CRPC) Patients With Germline Mutation in DNA-repair Genes 

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:

王备合 

研究负责人:

叶定伟 

Applicant:

Beihe Wang 

Study leader:

Dingwei Ye 

申请注册联系人电话:

Applicant telephone:

+86 021-64175590 

研究负责人电话:

Study leader's telephone:

+86 021-64175590 

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:

med_wangbh@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dwyeli_uro@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:

上海市徐汇区东安路270号 

研究负责人通讯地址:

上海市徐汇区东安路270号 

Applicant address:

270 Dong'an Road, Xuhui District, Shanghai, China 

Study leader's address:

270 Dong'an Road, Xuhui District, Shanghai, 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:

复旦大学附属肿瘤医院 

Applicant's institution:

Fudan University Shanghai Cancer Center 

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:

复旦大学附属肿瘤医院 

Primary sponsor:

Fudan University Shanghai Cancer Center 

研究实施负责(组长)单位地址:

上海市徐汇区东安路270号 

Primary sponsor's address:

270 Dong'an Road, Xuhui Distric, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属肿瘤医院

具体地址:

上海市徐汇区东安路270号

Institution
hospital:

Fudan University Shanghai Cancer Center

Address:

270 Dong'an Road, Xuhui District, Shanghai

经费或物资来源:

复旦大学附属肿瘤医院 

Source(s) of funding:

Fudan University Shanghai Cancer Center 

研究疾病:

前列腺癌 

Target disease:

Prostate Cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究是一项针对可以接受药物治疗并具有DNA修复基因胚系突变的去势抵抗性前列腺癌(CRPC)患者的前瞻性队列研究。研究旨在评价DNA修复基因突变对CRPC患者核医学影像病灶检出率的影响及检出病灶间异质性。 

Objectives of Study:

The current study is a prospective observational cohort study for castration resistant prostate cancer (CRPC) patients with germline mutation in DNA-repair genes at study entry and who are candidate to start any approved agent for prostate cancer. The study aims to evaluate the impact of aberrations in DNA-repair genes on radiologic findings and the heterogeneity between lesions in CRPC 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. 18岁以上并自愿签署知情同意书; 2. 病理学或细胞学确诊的前列腺腺癌,无神经内分泌分化,无印戒细胞癌或小细胞癌分化; 3. 去势抵抗性前列腺癌诊断明确,并且转移高风险;具体定义为在持续雄激素剥夺治疗下(双侧睾丸切除、使用促性腺激素释放激素类似物或拮抗剂治疗),PSA倍增时间≤10个月; 4. 具有以下基因的胚系突变: TM, ATR, BRCA2, BRCA1, BRIP1, CDK12, CHEK2, ERCC3, ERCC4, FANCA, FAM175A, GEN1, MRE11, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D; 5. ECOG评分≤1; 6. 预期寿命≥12个月。 

Inclusion criteria

1. Aged 18 years or older and willing and able to provide informed consent; 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation; signet cell; or small cell features; 3. Confirmed castration resistant prostate cancer at high risk for the development of metastasis; which was defined as a PSA doubling time of 10 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists); 4. Germline mutation carriers inTM, ATR, BRCA2, BRCA1, BRIP1, CDK12, CHEK2, ERCC3, ERCC4, FANCA, FAM175A, GEN1, MRE11, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D; 5. ECOG≤1; 6. Estimated life expectancy ≥ 12 months. 

排除标准:

1. 入组前3年内曾有另外一种浸润性癌疾病史,除非已经充分治疗并且经医疗监测人员及研究者共同评估后认为复发概率极低; 2. 具有研究者认为可能会影响获取知情同意或影响研究安全性的医疗疾病史。 

Exclusion criteria:

1. History of another invasive cancer within 3 years of enrollment, with the exception of fully treated cancers with a remote probability of recurrence in the opinion of both the medical monitor and investigator; 2. Any prior medical history that according to the judgement of the investigator might interfere with the subject′s granting of informed consent or the safe execution of the procedures required in the study. 

研究实施时间:

Study execute time:

From2019-04-20To 2022-04-20 

干预措施:

Interventions:

组别:

研究组

样本量:

100

Group:

Case series

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

Not Appicable

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Fudan University Shanghai Cancer Center  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

核医学影像检出病灶间的异质性,包括局部/盆腔转移及远处转移

指标类型:

主要指标 

Outcome:

Radiologic heterogeneity between lesions detected by nuclear imaging including local/pelvic disease and distant metastatic (M1) disease

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核医学影像发现与患者预后间关系

指标类型:

次要指标 

Outcome:

Correlation of radiologic findings with survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核医学影像表现与不用治疗方案疗效间关系

指标类型:

次要指标 

Outcome:

Correlation of radiologic response with treatment schemes

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:

血液

组织:

Sample Name:

Blood

Tissue:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

无随机

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

not appicable

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

联系人邮件索取

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

The metadata and protocol could be required by email

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:

电子采集和管理系统

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

EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-21
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