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Dynamic monitoring of ctDNA and prediction of immune efficacy in advanced NSCLC patients with wild-type gene and feasibility study based on ctDNA level intervention
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注册号:

Registration number:

ChiCTR2100052222 

最近更新日期:

Date of Last Refreshed on:

2021-10-23 

注册时间:

Date of Registration:

2021-10-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

ctDNA 动态监控与晚期初治驱动基因野生型 NSCLC 患者免疫疗效预测及基于 ctDNA 水平进行干预的可行性研究 

Public title:

Dynamic monitoring of ctDNA and prediction of immune efficacy in advanced NSCLC patients with wild-type gene and feasibility study based on ctDNA level intervention 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ctDNA 动态监控与晚期初治驱动基因野生型 NSCLC 患者免疫疗效预测及基于 ctDNA 水平进行干预的可行性研究 

Scientific title:

Dynamic monitoring of ctDNA and prediction of immune efficacy in advanced NSCLC patients with wild-type gene and feasibility study based on ctDNA level intervention 

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:

杨锦 

研究负责人:

项轶 

Applicant:

Yang Jin 

Study leader:

Xiang Yi 

申请注册联系人电话:

Applicant telephone:

+86 18895612117 

研究负责人电话:

Study leader's telephone:

+86 13816967846 

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:

1392947597@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xiangyiht@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:

上海市瑞金二路 197号上海交通大学36号楼 

研究负责人通讯地址:

上海市瑞金二路 197 号上海交通大学36号楼 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu 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:

上海交通大学医学院 

Applicant's institution:

Shanghai Jiao Tong University School of Medicine 

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:

(2020)临伦审第(346)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:

上海交通大学医学院瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin Hospital Ethics Committee ShangHai JiaoTong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-11-17 

伦理委员会联系人:

王译锋 

Contact Name of the ethic committee:

Wang Yifeng 

伦理委员会联系地址:

上海市瑞金二路 197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Huangpu 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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市瑞金二路 197号 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu 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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

瑞金二路 197号

Institution
hospital:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

非小细胞肺癌 

Target disease:

non-small cell lung cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

探讨PD-1抑制剂免疫单药和/或免疫联合化疗治疗过程中ctDNA动态变化与免疫治疗应答水平(1年PFS率,PFS)的相关性。 

Objectives of Study:

To explore the correlation between the dynamic changes of ctDNA and the response level of immunotherapy (1 year PFS rate, PFS) during the course of immunotherapy with PD-1 inhibitors and/or immunocombined chemotherapy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 组织学或细胞学确诊的AJCC TNM分期(第8版)IIIB/IV期NSCLC患者 2. 既往未接受过针对晚期NSCLC的一线抗肿瘤全身治疗; 3. PS评分0-1分; 4. 身体状况和器官功能允许开展抗肿瘤全身治疗,包括标准化疗及免疫药物治疗; 5. 有影像学可评估病灶; 6. 无症状脑转移或经局部治疗症状稳定的脑转移患者可入组; 7. 签署知情同意书时,年龄≥18岁; 8. 具有一线治疗开始前的血标本和/或肿瘤组织标本NGS、免疫微环境相关多色免疫荧光组化检测结果; 9. 患者有能力遵循计划的日程,积极配合回到医院进行规律的临床随访及必要的治疗; 10. 可以提供研究所需的临床资料,并愿意将检测数据用于进一步科研利用及商业产品开发。 

Inclusion criteria

1. Stage III and IV non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be unresectable (International Association for the Study of Lung Cancer Eighth Edition Lung Cancer Staging). 2. Patients have not received first-line anti-tumor systemic therapy 3. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 or 1; 4. The physical condition and organ function allow to carry out anti-tumor systemic treatment, including standard chemotherapy and immunopharmaceutical treatment; 5. There is imaging to assess the lesion of tumor; 6. Patients with brain metastases are asymptomatic or have stable symptoms with local treatment; 7. The patients' age are over 18 years old when signs the informed consent form; 8. Blood samples and/or tumor tissue samples ,immune microenvironment-related multicolor immunofluorescence histochemical test results had collected before the start of first-line treatment NGS; 9. The patient has the ability to follow the planned schedule and actively cooperate with returning to the hospital for regular clinical follow-up and necessary treatment; 10. Patients who can provide the clinical data needed for research, and is willing to use the test data for further scientific research and commercial product development. 

排除标准:

1. 入组前5年内患有其它活动性恶性肿瘤。已治愈的局限性肿瘤,如皮肤基底细胞癌、皮肤鳞癌、表浅膀胱癌、前列腺原位癌、宫颈原位癌、乳腺原位癌等可以入组; 2. 既往已接受过针对晚期NSCLC的全身抗肿瘤治疗、而无基线血标本NGS检测结果的患者; 3. 经研究者判断,同时患有可能影响随访和/或显著缩短生存的其他严重疾病的患者; 4. 伴有任何其他病情和社会/心理问题等、经研究者判断不适合参与本研究的患者; 5. 不能接受使用造影剂增强的磁共振成像(MRI)或造影剂增强的计算机断层扫描(CT) 进行临床随访的患者。 

Exclusion criteria:

1. Patients suffered from other active malignant tumors within 5 years before enrollment. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group; 2. Advanced NSCLC patients who have previously received systemic anti-tumor therapy and have no baseline blood sample NGS test results 3. As judged by the investigator, patients who also suffer from other serious diseases that may affect follow-up and/or significantly shorten survival; 4. Patients who are accompanied by any other medical conditions and social/psychological problems, etc., who are judged by the investigator to be unsuitable to participate in this study; 5. Patients who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for clinical follow-up. 

研究实施时间:

Study execute time:

From2020-11-01To 2022-10-31 

征募观察对象时间:

Recruiting time:

From2020-11-01To 2022-10-31 

干预措施:

Interventions:

组别:

Part1

样本量:

20

Group:

Part1

Sample size:

干预措施:

no intervention

干预措施代码:

Intervention:

no intervention

Intervention code:

组别:

Part 2 PD-L1>= 50%

样本量:

60

Group:

Part 2 PD-L1>= 50%

Sample size:

干预措施:

联合或者不联合化疗

干预措施代码:

Intervention:

with or without chemotherapy

Intervention code:

组别:

Part 2 PD-L1< 50%

样本量:

60

Group:

Part 2 PD-L1< 50%

Sample size:

干预措施:

联合或者不联合化疗

干预措施代码:

Intervention:

with or without chemotherapy

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):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine  

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:

circulating tumor DNA

Type:

Primary indicator 

测量时间点:

免疫治疗之前, 免疫治疗3-4周后, 免疫治疗6-8周后

测量方法:

Measure time point of outcome:

Before immunotherapy, after 3-4 weeks of immunotherapy, after 6-8 weeks of immunotherapy

Measure method:

指标中文名:

程序性死亡因子配体

指标类型:

主要指标 

Outcome:

Programmed cell death 1 ligand 1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基本生命体征

指标类型:

次要指标 

Outcome:

basic vital signs

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

组织

组织:

Sample Name:

tissue

Tissue:

lung

人体标本去向

使用后保存 

说明

保存5年

Fate of sample:

Preservation after use 

Note:

Save for 5 years

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):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

No

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):

原始数据将于试验完成后6个月内上传至ResMan平台进行公开

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

The protocol and metadata would be publicly disclosed within six months after the trial complete and uploaded to ResMan.

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:

临床原始数据统一记录于瑞金医院住院信息系统中,病例记录表纸质版统一由主要研究者保管于文件夹中。

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

Original clinical data were recorded in in-patient information management system of Ruijin Hospital. Case reporting forms were all saved in a folder by study leader.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-10-22
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