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注册号: Registration number: |
ChiCTR2600121038 |
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最近更新日期: Date of Last Refreshed on: |
2026-03-24 16:56:31 |
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注册时间: Date of Registration: |
2026-03-24 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
非亲缘供者造血干细胞捐献意愿的心路历程 |
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Public title: |
The Journey of Willingness to Donate Hematopoietic Stem Cells |
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注册题目简写: |
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English Acronym: |
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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 |
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Scientific title: |
Study on the Mechanism of the Willingness to Donate Hematopoietic Stem Cells |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
胡期 |
研究负责人: |
卢其玲 |
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Applicant: |
Hu Qi |
Study leader: |
Lu Qiling |
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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 |
+86 138 0354 2367 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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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 |
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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): |
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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 |
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Applicant address: |
No.461, Bayi Avenue, Nanchang City, Jiangxi Province |
Study leader's address: |
No.92, Aiguo Road, Nanchang City, Jiangxi Province |
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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 |
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申请人所在单位: |
南昌大学江西医学院 |
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Applicant's institution: |
Nanchang University Jiangxi Medical College |
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研究负责人所在单位: |
江西省人民医院 |
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Affiliation of the Leader: |
Jiangxi Provincial People's Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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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 |
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Name of the ethic committee: |
Medical Ethics Committee of Jiangxi Provincial People's Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-10-03 00:00:00 | ||
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伦理委员会联系人: |
陈志平 |
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Contact Name of the ethic committee: |
Cheng Zhi Ping |
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伦理委员会联系地址: |
江西省南昌市爱国路152号 |
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Contact Address of the ethic committee: |
No.152, Aiguo Road, Nanchang City, Jiangxi Province |
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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: |
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研究实施负责(组长)单位: |
江西省人民医院 |
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Primary sponsor: |
Jiangxi Provincial People's Hospital |
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研究实施负责(组长)单位地址: |
江西省南昌市爱国路92号 |
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Primary sponsor's address: |
No.92, Aiguo Road, Nanchang City, Jiangxi Province |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
无资助 |
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Source(s) of funding: |
No Funding |
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研究疾病: |
白血病(造血干细胞移植) |
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Target disease: |
Leukemia (hematopoietic stem cell transplantation) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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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。 |
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Objectives of Study: |
To explore the influencing factors of hematopoietic stem cell donation from unrelated donors and provide reference for improving donation willingness. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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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; |
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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; |
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研究实施时间: Study execute time: |
从 From 2026-03-01 00:00:00至 To 2027-09-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-03-25 00:00:00 至 To 2026-06-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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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. |
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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 |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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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): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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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 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Interview record; voice recording |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |