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The metabolites analysis of tumor patients after HF1K16 treatment based on LC-MS/MS technology
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注册号:

Registration number:

ChiCTR2200059761 

最近更新日期:

Date of Last Refreshed on:

2022-05-11 

注册时间:

Date of Registration:

2022-05-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理审查文件。 基于LC-MS/MS技术分析肿瘤患者经HF1K16治疗后体内代谢产物变化研究 

Public title:

The metabolites analysis of tumor patients after HF1K16 treatment based on LC-MS/MS technology 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于LC-MS/MS技术分析肿瘤患者经HF1K16治疗后体内代谢产物变化研究 

Scientific title:

The metabolites analysis of tumor patients after HF1K16 treatment based on LC-MS/MS technology 

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:

林美花 

研究负责人:

刘健、张晓琛 

Applicant:

Meihua Lin 

Study leader:

Jian Liu; Xiaochen Zhang 

申请注册联系人电话:

Applicant telephone:

13757638268 

研究负责人电话:

Study leader's telephone:

13958054006 

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:

mhlin2015@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

lindaliu87@zju.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

浙江大学医学院附属第一医院 

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:

浙江省杭州市上城区庆春路79号 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang 

申请注册联系人邮政编码:

Applicant postcode:

310003 

研究负责人邮政编码:

Study leader's postcode:

310003 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affliated Hospital, Zhejiang 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:

浙大一院伦审2022研第419号-快 

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:

浙江大学医学院附属第一医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-05-03 

伦理委员会联系人:

吕朵、黄鑫 

Contact Name of the ethic committee:

Duo Lv; Xin Huang 

伦理委员会联系地址:

浙江省杭州市上城区庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang 

伦理委员会联系人电话:

Contact phone of the ethic committee:

057187236596 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affliated Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市上城区庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

The First Affliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road, Hangzhou, Zhejiang

经费或物资来源:

N/A 

Source(s) of funding:

N/A 

研究疾病:

肿瘤 

Target disease:

Tumor 

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:

I期临床试验 

Study phase:

研究目的:

探究HF1K16多剂量给药治疗后体内代谢产物变化与HF1K16暴露量、免疫细胞活性及初步有效性间相关性,探索潜在的生物标志物。 

Objectives of Study:

To explore the correlation between metabolite changes and HF1K16 exposure, immune cell activity and initial effectiveness after HF1K16 multi-dose therapy, and explore potential biomarkers. 

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)HF1K16-101临床试验的正式入组受试者,且参与HF1K16多剂量给药治疗; 2)知情同意愿意参加本研究受试者。 

Inclusion criteria

1) Subjects who are officially enrolled in HF1K16-101 clinical trials and participate in HF1K16 multi-dose administration; 2) Subjects willing to participate in the study with informed consent. 

排除标准:

1)HF1K16-101临床试验的正式入组受试者,但不参与HF1K16多次给药; 2)不能按规定血液采集或尿液和粪便标本留取的受试者; 3)研究者认为不合适参与本研究的其他情况。 

Exclusion criteria:

1) Subjects who are officially enrolled in the HF1K16-101 clinical trial but do not participate in multiple dosing of HF1K16; 2) subjects who cannot collect blood or urine and faeces samples as required; 3) Other circumstances that the researcher considers inappropriate to participate in this study. 

研究实施时间:

Study execute time:

From2022-05-03To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2022-05-03To 2023-12-31 

干预措施:

Interventions:

组别:

N/A

样本量:

12

Group:

N/A

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Grade three hospital 

测量指标:

Outcomes:

指标中文名:

评估HF1K16治疗后,体内代谢产物(氨基酸、有机酸、脂肪酸、还原糖、胆汁酸等300多种代谢物)变化

指标类型:

主要指标 

Outcome:

Analysis of the changes of metabolites (amino acids, organic acids, fatty acids, reducing sugars, bile acids and more than 300 metabolites) in vivo after HF1K16 treatment

Type:

Primary indicator 

测量时间点:

试验结束

测量方法:

液相色谱-串联质谱法

Measure time point of outcome:

End of Trial

Measure method:

LC-MS/MS

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:

尿液

组织:

Sample Name:

urine

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:

粪便

组织:

Sample Name:

faeces

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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:

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):

N/A

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

N/A

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:

N/A

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

N/A

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-05-11
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