Today is 2020-08-05

Clinical study of circulating tumor DNA as a prognostic biomarker for esophageal cancer
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注册号:

Registration number:

ChiCTR2000034355 

最近更新日期:

Date of Last Refreshed on:

2020-07-04 

注册时间:

Date of Registration:

2020-07-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

循环肿瘤DNA作为食管癌预后标志物的临床研究 

Public title:

Clinical study of circulating tumor DNA as a prognostic biomarker for esophageal cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

循环肿瘤DNA作为食管癌预后标志物的临床研究 

Scientific title:

Clinical study of circulating tumor DNA as a prognostic biomarker for esophageal cancer 

研究课题代号(代码):

Study subject ID:

15411951700 

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:

刘涛 

研究负责人:

金海 

Applicant:

Liu Tao 

Study leader:

Jin Hai 

申请注册联系人电话:

Applicant telephone:

+86 18518757663 

研究负责人电话:

Study leader's telephone:

+86 13601870779 

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:

liu-ta0@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

projinhai@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:

上海市杨浦区长海路168号长海医院胸外科 

研究负责人通讯地址:

上海市杨浦区长海路168号长海医院胸外科 

Applicant address:

168 Changhai Road, Yangpu District, Shanghai, China 

Study leader's address:

168 Changhai Road, Yangpu 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:

上海市长海医院胸外科 

Applicant's institution:

Department of thoracic surgery, Shanghai Changhai 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:

CHEC2020-021 

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:

上海长海医院伦理委员会 

Name of the ethic committee:

Shanghai Changhai Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-05 

伦理委员会联系人:

纪伟平 

Contact Name of the ethic committee:

Ji Weiping 

伦理委员会联系地址:

上海市杨浦区长海路168号长海医院伦理委员会 

Contact Address of the ethic committee:

Shanghai Changhai Hospital Ethics Committee, Changhai Hospital, 168 Changhai Road, Yangpu District, Shanghai, 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:

上海市长海医院 

Primary sponsor:

Shanghai Changhai Hospital 

研究实施负责(组长)单位地址:

上海市杨浦区长海路168号长海医院 

Primary sponsor's address:

168 Changhai Road, Yangpu District, 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

市(区县):

上海

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海市长海医院

具体地址:

上海市杨浦区长海路168号长海医院

Institution
hospital:

Shanghai Changhai Hospital

Address:

168 Changhai Road, Yangpu District

经费或物资来源:

省级科研基金,循环肿瘤DNA检测在食管鳞癌诊断治疗中的应用研究,项目编号:15411951700 

Source(s) of funding:

Provincial scientific research fund, the application of circulating tumor DNA detection in the diagnosis and treatment of esophageal squamous cell carcinoma, project number: 15411951700 

研究疾病:

食管癌 

Target disease:

Esophageal cancer 

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:

通过收集食管癌患者治疗前及治疗后多个时间点的外周血,通过ctDNA进行动态监测,分析基于ctDNA疗效/复发预测与影像学监测及血清标志物的一致性和准确性,评估ctDNA作为预后监测(疗效预测,微小残留病,复发预测)标志物的作用,综合评估基于ctDNA的液体活检方法在胸部肿瘤精准化诊疗中的应用。 

Objectives of Study:

The peripheral blood of patients with esophageal cancer is collected before and after treatment, and dynamic monitoring is carried out by ctDNA. The consistency and accuracy of ctDNA efficacy / recurrence prediction, imaging monitoring and serum markers are analyzed, and the role of ctDNA as a prognostic marker (efficacy prediction, minimal residual disease, recurrence prediction) is evaluated. The application of liquid biopsy based on ctDNA in accurate diagnosis and treatment of chest tumors was evaluated comprehensively. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

纳入标准: 1)年龄≥18岁; 2)临床或者病理确诊的I-III期食管癌初诊患者,在第一次采血前未经任何抗肿瘤治疗; 3) ECOG评分0或1分; 4) 受试者和家属能够理解研究方案并愿意参与本研究,提供书面知情同意。 

Inclusion criteria

Inclusion criteria: 1. Patients with aged >=18 years old; 2. Patients with clinically or pathologically diagnosed stage I-III esophageal cancer did not receive any anti-tumor treatment before the first blood collection; 3. ECoG score 0 or 1; 4. The subjects and their family members were able to understand the study protocol and were willing to participate in the study and provide written informed consent. 

排除标准:

1)近期(抽血前14天)有急重症疾病引发炎症反应。 或抽血前14天内使用过激素治疗; 2)合并其他肿瘤疾病史,或合并其他遗传性疾病; 3)接受过器官移植、干细胞移植、骨髓移植或近1个月接受过输血; 4)怀孕妇女; 5)近60天内正在参加其他需要服用药物的临床试验(包括肠道准备、麻醉等); 6)严重心血管疾病、无法控制的感染、或其他无法控制的合并疾病; 7)病人或家属无法理解本研究的条件和目标。 退出与剔除: 1) 受试者或其法定监护人主动要求退出; 2) 违反入选/排除标准; 3) 出现其他不可解释之严重合并症时退出; 4) 如果治疗过程中发生妊娠,退出研究; 5) 出于安全原因,研究申办方提出停止研究; 6) 伦理委员会决定停止研究的受试者; 7) 研究者认为不适合继续参与研究的受试者。 注:对中途退出的受试者详细记录其退出的理由与日期,研究结束统计退出率。退出研究的受试者将根据各中心研究者的判断进行适合的治疗措施。 

Exclusion criteria:

Exclusion criteria: 1. Patients with inflammatory reaction caused by acute and severe diseases in recent period (14 days before blood drawing); or hormone therapy was used in 14 days before blood drawing; 2. Patients with a history of other tumor diseases or with other genetic diseases; 3. Patients who have received organ transplantation, stem cell transplantation, bone marrow transplantation or blood transfusion in recent one month; 4. Pregnant women; 5. Patients who are participating in other clinical trials (including bowel preparation, anesthesia, etc.) who need to take drugs in the past 60 days; 6. Patients with severe cardiovascular disease, uncontrolled infection, or other uncontrollable comorbidities; 7. Patients or family members could not understand the conditions and objectives of this study. Drop-out or withdraw: 1. The subjects or their legal guardians asked to withdraw voluntarily; 2. Patients who violate the inclusion / exclusion criteria; 3. Patients who quit when other unexplained serious complications occur; 4. If pregnancy occurs during the treatment, withdraw from the study; 5. For safety reasons, the sponsor proposed to stop the study; 6. Subjects whose ethics committee decided to stop the study; 7. Subjects who are considered unsuitable by the researcher to continue to participate in the study. Note: the reason and date of withdrawal were recorded in detail, and the withdrawal rate was counted at the end of the study. The subjects who withdrew from the study will take appropriate treatment measures according to the judgment of the researchers in each center. 

研究实施时间:

Study execute time:

From2020-07-02To 2023-07-02 

征募观察对象时间:

Recruiting time:

From2020-07-02To 2020-12-31 

诊断措施:

Diagnostic measures:

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):

临床结局

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):

Clinical outcomes

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):

ctDNA进行动态监测

Index test:

dynamic monitoring is carried out by ctDNA

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)

I-III期食管癌初诊患者

例数:

Sample size:

50

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):

stage I-III esophageal cancer 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):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市长海医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Changhai Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

循环肿瘤DNA

指标类型:

主要指标 

Outcome:

ctDNA

Type:

Primary indicator 

测量时间点:

多时间点

测量方法:

高通量测序

Measure time point of outcome:

Mutilple times

Measure method:

NGS

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

外周血

组织:

食管

Sample Name:

Blood

Tissue:

Esophageal

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:

尚未开始

Not yet recruiting

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):

本研究不涉及随机分组

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

Non-randomization

盲法:

未说明

Blinding:

Not stated

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):

在试验完成后6个月内公开

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

Within 6 months after completion of the trial

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-03
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