湖南人群前列腺癌分子流行病学分析

注册号:

Registration number:

ITMCTR2200005999

最近更新日期:

Date of Last Refreshed on:

2022-05-12

注册时间:

Date of Registration:

2022-05-12

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

湖南人群前列腺癌分子流行病学分析

Public title:

Molecular epidemiological analysis of prostate cancer in Hunan population

注册题目简写:

English Acronym:

研究课题的正式科学名称:

湖南人群前列腺癌分子流行病学分析及温肾活血解毒法干预的研究

Scientific title:

Molecular epidemiological analysis of prostate cancer in Hunan population and research on the intervention of warming the kidney and promoting blood circulation and detoxification

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200059842 ; ChiMCTR2200005999

申请注册联系人:

高瑞松

研究负责人:

周青

Applicant:

Gao RuiSong

Study leader:

ZHOU Qing

申请注册联系人电话:

Applicant telephone:

15116405127

研究负责人电话:

Study leader's telephone:

13574855248

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:

448532089@qq.com

研究负责人电子邮件:

Study leader's E-mail:

supergoon@163.com

申请单位网址(自愿提供):

Study leader's 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:

湖南省长沙市雨花区韶山中路95号湖南中医药大学第一附属医院

研究负责人通讯地址:

湖南省长沙市雨花区韶山中路95号湖南中医药大学第一附属医院

Applicant address:

The First Affiliated Hospital of Hunan University of Chinese Medicine, No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

Study leader's address:

The First Affiliated Hospital of Hunan University of Chinese Medicine, No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

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:

湖南中医药大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

HN-LL-KY-2022-014-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

湖南中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Hunan University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/3/3 0:00:00

伦理委员会联系人:

雍苏南

Contact Name of the ethic committee:

Yong Su-Nang

伦理委员会联系地址:

湖南省长沙市雨花区韶山中路95号湖南中医药大学第一附属医院

Contact Address of the ethic committee:

The First Affiliated Hospital of Hunan University of Chinese Medicine, No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

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:

湖南中医药大学第一附属医院

Primary sponsor:

the First Affiliated Hospital of Hunan University of Chinese Medicine

研究实施负责(组长)单位地址:

湖南省长沙市雨花区韶山中路95号湖南中医药大学第一附属医院

Primary sponsor's address:

The First Affiliated Hospital of Hunan University of Chinese Medicine, No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

湖南中医药大学第一附属医院

具体地址:

湖南省长沙市雨花区韶山中路95号湖南中医药大学第一附属医院

Institution
hospital:

the First Affiliated Hospital of Hunan University of Chinese Medicine

Address:

The First Affiliated Hospital of Hunan University of Chinese Medicine, No. 95, Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

前列腺癌

研究疾病代码:

Target disease:

prostate cancer

Target disease code:

研究类型:

Study type:

流行病学研究

Epidemilogical research

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

完成PCa可疑人群筛选与验证早期诊断生物标志物。

Objectives of Study:

Screening of suspected population with PCa and validation of biomarkers for early diagnosis were completed.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

前列腺动态未定或动态未知的肿瘤,需要接受前列腺穿刺活检者。①直肠指诊发现前列腺可疑结节,任何前列腺特异性抗原值;②经直肠前列腺超声检查或MRI发现可疑病灶,而前列腺特异性抗原正常者;③前列腺特异性抗原>10 ng/ml;④前列腺特异性抗原4~10 ng/ml,游离前列腺特异性抗原/总游离前列腺特异性抗(fPSA/tPSA)可疑。符合前两项者,无论前列腺特异性抗原数值高低均需行前列腺穿刺活检。

Inclusion criteria

Patients with undetermined or unknown prostate dynamic tumors requiring prostate needle biopsy. ① Suspicious prostate nodules on digital rectal examination, any prostate-specific antigen values; ② Transrectal prostate ultrasound or MRI found suspicious lesions with normal prostate-specific antigen; ③ Prostate specific antigen > 10 ng/ mL; ④ Prostate-specific antigen was 4-10 ng/ mL, and free prostate-specific antigen/total free prostate-specific antibody (fPSA/tPSA) was suspicious. Patients in line with the first two criteria should undergo prostate puncture biopsy regardless of the value of psa.

排除标准:

①已确诊为前列腺癌的患者;②患有严重的心、脑、 肝、肾类疾病,不耐受前列腺穿刺活检;③不愿意接受前列腺穿刺活检者。

Exclusion criteria:

① Patients who have been diagnosed with prostate cancer; ② Patients with serious heart, brain, liver and kidney diseases and intolerance to prostate biopsy; ③ Those who are unwilling to receive needle biopsy of prostate.

研究实施时间:

Study execute time:

From 2022-05-01

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2022-05-01

To      2024-12-31

干预措施:

Interventions:

组别:

高危组

样本量:

60

Group:

The high risk group

Sample size:

干预措施:

前列腺穿刺活检

干预措施代码:

Intervention:

Needle biopsy of prostate

Intervention code:

组别:

验证组

样本量:

60

Group:

Validation group

Sample size:

干预措施:

按摩取前列液

干预措施代码:

Intervention:

Massage to get prostate fluid

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

湖南

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

湖南中医药大学第一附属医院

单位级别:

三甲医院

Institution/hospital:

the First Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution:

tertiary hospital

测量指标:

Outcomes:

指标中文名:

差异代谢物

指标类型:

主要指标

Outcome:

Differential metabolites

Type:

Primary 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:

前列腺液

组织:

前列腺

Sample Name:

Prostate fluid

Tissue:

Prostate

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:

前列腺组织

组织:

前列腺

Sample Name:

Prostate tissue

Tissue:

Prostate

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

简单随机法,在整个研究中心按照受试者入选的先后顺序,根据预定的随机方案分配入试验组或对照组。随机方案由研究人员易港通过查阅随机对照表产生。

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

In the simple randomization method, subjects are assigned to the treatment group or control group according to a predetermined randomization protocol in the order of their enrollment throughout the study center. The randomization scheme was generated by researcher Yi Gang by looking at a randomization comparison ta

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

通过湖南中医大学第一附属医院科研科于2025.06.30公开原始数据

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

The original data was released through the Scientific Research Department of the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine on 2025.06.30

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:

使用病例记录表采集和管理数据。

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

Collect and manage data using CRF.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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