非亲缘供者造血干细胞捐献意愿的心路历程

注册号:

Registration number:

ChiCTR2600121038 

最近更新日期:

Date of Last Refreshed on:

2026-03-24 16:56:31 

注册时间:

Date of Registration:

2026-03-24 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

非亲缘供者造血干细胞捐献意愿的心路历程

Public title:

The Journey of Willingness to Donate Hematopoietic Stem Cells

注册题目简写:

English Acronym:

研究课题的正式科学名称:

造血干细胞捐献意愿的机制研究

Scientific title:

Study on the Mechanism of the Willingness to Donate Hematopoietic Stem Cells

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:

胡期 

研究负责人:

卢其玲 

Applicant:

Hu Qi 

Study leader:

Lu Qiling 

申请注册联系人电话:

Applicant telephone:

+86 152 7084 3619

研究负责人电话:

Study leader's
telephone:

+86 138 0354 2367

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:

3163556142@qq.com

研究负责人电子邮件:

Study leader's E-mail:

173556319@qq.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:

江西省南昌市八一大道461号

研究负责人通讯地址:

江西省南昌市爱国路92号

Applicant address:

No.461, Bayi Avenue, Nanchang City, Jiangxi Province

Study leader's address:

No.92, Aiguo Road, Nanchang City, Jiangxi Province

申请注册联系人邮政编码:

Applicant postcode:

330006

研究负责人邮政编码:

Study leader's postcode:

330006

申请人所在单位:

南昌大学江西医学院

Applicant's institution:

Nanchang University Jiangxi Medical College

研究负责人所在单位:

江西省人民医院

Affiliation of the Leader:

Jiangxi Provincial People's Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

科快2025(45)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:

江西省人民医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Jiangxi Provincial People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2025-10-03 00:00:00

伦理委员会联系人:

陈志平

Contact Name of the ethic committee:

Cheng Zhi Ping

伦理委员会联系地址:

江西省南昌市爱国路152号

Contact Address of the ethic committee:

No.152, Aiguo Road, Nanchang City, Jiangxi Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 181 7913 3991

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:

江西省人民医院

Primary sponsor:

Jiangxi Provincial People's Hospital

研究实施负责(组长)单位地址:

江西省南昌市爱国路92号

Primary sponsor's address:

No.92, Aiguo Road, Nanchang City, Jiangxi 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):

江西

市(区县):

南昌

Country:

China

Province:

Jiang Xi

City:

Nan Chang

单位(医院):

江西省人民医院

具体地址:

江西省南昌市爱国路92号

Institution
hospital:

Jiangxi Provincial People's Hospital

Address:

No.92, Aiguo Road, Nanchang City, Jiangxi Province

经费或物资来源:

无资助

Source(s) of funding:

No Funding

研究疾病:

白血病(造血干细胞移植)  

Target disease:

Leukemia (hematopoietic stem cell transplantation)

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

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

探究非亲缘供者捐献造血干细胞行为的影响因素,为提升捐献意愿提供参考。  

Objectives of Study:

To explore the influencing factors of hematopoietic stem cell donation from unrelated donors and provide reference for improving donation willingness.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.存在认知障碍或精神心理疾病; 2.患有恶性肿瘤或严重器质性疾病; 3.个人或家庭近期发生重大灾害事件; 4.拒绝对访谈内容进行记录;

Exclusion criteria:

1. Presence of cognitive impairment or mental psychological disorders; 2. Suffering from malignant tumors or severe organic diseases; 3. Recent major disaster events occurring to the individual or family; 4. Refusal to allow recording of interview content;

研究实施时间:

Study execute time:

From 2026-03-01 00:00:00 To 2027-09-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-03-25 00:00:00 To 2026-06-30 00:00:00

干预措施:

Interventions:

组别:

调查组

样本量:

14

Group:

Investigation Group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

江西省 

市(区县):

南昌 

Country:

China

Province:

Jiang Xi

City:

Nan Chang

单位(医院):

江西省人民医院 

单位级别:

三甲 

Institution
hospital:

Jiangxi Provincial People's Hospital

Level of the institution:

Tertiary, Tertiary A

测量指标:

Outcomes:

指标中文名:

访谈文本(一对一访谈的文本资料)

指标类型:

主要指标

Outcome:

Interview transcript (textual material from one-on-one interviews)

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:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 18 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):

采用目的抽样法,选取2024年12月—2025年7月在江西省人民医院血液科移植病房捐献的14例造血干细胞非亲缘供者极其陪同亲属一位

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

A total of 14 hematopoietic stem cell (HSC) non-consanguineous donors and one accompanying relative were selected from the Transplantation Ward of the Hematology Department at Jiangxi Provincial People's Hospital between December 2024 and July 2025 using purposive sampling.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

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

None

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:

访谈资料记录本;录音笔录制语音

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

Interview record; voice recording

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-03-24 16:56:02