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ω-3多不饱和脂肪酸与孤立性及多发性肺结节真实世界研究
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注册号:

Registration number:

ChiCTR1900025873 

最近更新日期:

Date of Last Refreshed on:

2019-09-12 

注册时间:

Date of Registration:

2019-09-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

ω-3多不饱和脂肪酸与孤立性及多发性肺结节真实世界研究 

Public title:

Real-world study for the relationship between omega-3 polyunsaturated fatty acids and solitary & multiple pulmonary nodules 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ω-3多不饱和脂肪酸与孤立性及多发性肺结节真实世界研究 

Scientific title:

Real-world study for the relationship between omega-3 polyunsaturated fatty acids and solitary & multiple pulmonary nodules 

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:

牛桂兰 

研究负责人:

白春学,余金明,赵峰 

Applicant:

Guilan Niu 

Study leader:

Chunxue Bai, Jinming Yu, Feng Zhao 

申请注册联系人电话:

Applicant telephone:

+86 13166438092 

研究负责人电话:

Study leader's telephone:

+86 021-64041990 

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:

cr11@newsummitbio.com 

研究负责人电子邮件:

Study leader's E-mail:

bai.chunxue@zs-hospital.sh.cn 

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:

上海浦东新区蔡伦路780号 

研究负责人通讯地址:

上海市枫林路180号5号楼8层 

Applicant address:

780 Cailun Road, Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai 

Study leader's address:

8th Floor, Building 5, 180 Fenglin Road, Xuhui District, Shanghai 

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:

上海新生源医药集团有限公司 

Applicant's institution:

Shanghai Newsummit Biopharma Group 

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:

IRB#2019-01-0729 

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:

复旦大学公共卫生学院医学研究伦理委员会 

Name of the ethic committee:

IEC of School of Public Health Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-17 

伦理委员会联系人:

罗君 

Contact Name of the ethic committee:

Jun Luo 

伦理委员会联系地址:

上海市徐汇区东安路130号 

Contact Address of the ethic committee:

130 Dong'an Road, Xuhui District, Shanghai 

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:

上海市呼吸病研究所 

Primary sponsor:

Shanghai Institute of Respiratory Disease  

研究实施负责(组长)单位地址:

上海市枫林路180号5号楼8层 

Primary sponsor's address:

8th Floor, Building 5, 180 Fenglin Road, Xuhui District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东省

市(区县):

青岛市

Country:

China

Province:

Shandong

City:

Qingdao

单位(医院):

青岛大学营养健康研究院

具体地址:

登州路38号

Institution
hospital:

Institute of Nutrition and Health, Qingdao University

Address:

38 Dengzhou Road

经费或物资来源:

企业赞助 

Source(s) of funding:

Corporate sponsorship 

研究疾病:

孤立性及多发性肺结节 

Target disease:

solitary & multiple pulmonary nodules 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过生活方式调查问卷、临床资料收集、红细胞膜脂肪谱检测等,探讨n-3多不饱合脂肪酸水平与肺结节患者康复关联性,评价其降低肺结节恶变的效果。 

Objectives of Study:

Through the lifestyle questionnaire, the collection of clinical data and the detection for fat spectrum of erythrocyte membrane, etc., the relationship between ω-3 polyunsaturated fatty acid levels and rehabilitation of lung nodules patients was investigated. And the effect of ω-3 polyunsaturated fatty acid levels to lung nodule malignant transformation was also evaluated. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)年龄 19-60 岁,性别不限; 2)LDCT确诊为实性肺结节患者,且直径为4mm~8mm; 3)自愿参加并签署知情同意书。 

Inclusion criteria

1. Adult patients(Aged 19-60 years); 2. The person is diagnosed as a solid pulmonary nodules patient, exhibiting at least one lung nodule at diameter of 4mm-8mm by LDCT; 3. Patient have given its authorization for the exploitation of his medical data for this research and sign an ICF. 

排除标准:

1)4 周内参加过其他药物试验者; 2)患有严重疾病者; 3)有精神疾病史、药物依赖史、滥用药物史者、烟酒重瘾者; 4)最近 3 月内献血者; 5)心率<60 次/分或坐位静息血压<100/60 mmHg 者; 6)孕妇; 7)研究者认为不应纳入者。 

Exclusion criteria:

1) Those who have participated in other drug trials within 4 weeks; 2) Those suffering from serious diseases; 3) Those having history of mental illness, drug dependence, drug abuse, or alcohol and tobacco addiction; 4) Those who have participated blood donors in the last 3 months; 5) Person with heart rate <60 beats / min or sitting resting blood pressure <100/60 mmHg; 

研究实施时间:

Study execute time:

From2019-01-17To 2023-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

3600

Group:

experimental group

Sample size:

干预措施:

欧米伽3胶囊

干预措施代码:

Intervention:

Omega 3 capsule, Oral with meals, three times a day, four capsules at a time.

Intervention code:

组别:

对照组

样本量:

1200

Group:

control group

Sample size:

干预措施:

No

干预措施代码:

Intervention:

No

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):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui District 

单位(医院):

复旦大学附属中山医院 

单位级别:

三甲 

Institution
hospital:

Zhongshan Hospital, Fudan University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

河南省人民医院 

单位级别:

三甲 

Institution
hospital:

Henan Provincial People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

肺结节大小

指标类型:

主要指标 

Outcome:

Size of lung nodule

Type:

Primary indicator 

测量时间点:

按临床要求进行

测量方法:

低剂量螺旋CT

Measure time point of outcome:

0 month, 6th month,12th month, 18th month, 24th month

Measure method:

LDCT

指标中文名:

红细胞膜脂肪谱

指标类型:

主要指标 

Outcome:

Fat spectrum detection of erythrocyte membrane

Type:

Primary indicator 

测量时间点:

0月,12月, 24月

测量方法:

试剂盒

Measure time point of outcome:

0 month, 6th month,12th month, 18th month, 24th month

Measure method:

Kit

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:

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 19 years
最大 Max age 60 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):

非随机对照试验:由医生推荐,患者自行选择是否使用n-3,入组观察组还是对照组。

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

Non-randomized controlled trials: recommended by the doctor, the patient chooses whether to use the product of n-3, and to enter the observation group or the control group.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

试验完成后6个月内公开,采用临床试验公共管理平台ResMan向公众开放查询, http://www.medresman.org

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

Opened within 6 months after the completion of the trial, the public trial platform for clinical trials, ResMan, is open to the public, http://www.medresman.org

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:

病史、治疗过程以及监测结果记录于病历中,每一个病例均有CRF表格,于各研究中心单位保存。

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

The medical history, treatment process and monitoring results are recorded in the case records. Each case has a CRF form and is saved in each research center.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-09-12
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