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CIBMTR 研究数据库

英文原题:CIBMTR Research Database

查看英文原题

CIBMTR Research Database

ClinicalTrials.gov 2010/07/20(首次登记) 注册临床试验(分期未标注) · 招募中

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

⚠ 该试验的登记信息已有 14 个月未更新, 页面上显示的「招募中」可能已经失效。联系研究中心之前,建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于急性淋巴细胞白血病、实体瘤、恶性肿瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 99999999 例。试验地点:美国 · 明尼阿波利斯、密尔沃基(共 2 个中心)。登记号:NCT01166009。

入组条件决定能不能参加

不限性别

研究数据库受者资格:在CIBMTR中心接受无关或相关供者HSC移植或自体HSC移植的任何受者均可参加,包括具备或不具备决策能力的成人及儿童。骨髓毒性损伤患者资格:在参与NMDP放射损伤移植网络(RITN)的中心接受骨髓毒性损伤治疗的任何个人均可参加,包括具备或不具备决策能力的成人及儿童。符合条件者可仅接受支持治疗、生长因子支持、HSC移植或其他适当医疗治疗;治疗由照护机构决定,NMDP或CIBMTR不作决定。无关供者资格:所有在NMDP登记、且已被请求为受者捐献产品的供者均可参加研究数据库。所有母亲脐带血供者均纳入NMDP脐带血库研究性新药(IND)方案,并签署该方案专用知情同意书;脐带血库方案收集的数据也纳入研究数据库。
核对登记原文(英文)
Eligibility to Participate in the Research Database

Recipient Eligibility Criteria:

* Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.

Individual with Marrow Toxic Injury Eligibility Criteria:

* Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.

Unrelated Donor Eligibility Criteria:

* All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.
* All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点建立用于评估干细胞移植的综合观察性数据来源每年评估,平均频率。
  • 次要终点建立骨髓毒性损伤综合数据来源
  • 次要终点对Medicare参保患者异体造血细胞移植的前瞻性评估(17-CMS-SCD)
  • 次要终点对Medicare参保患者异体造血细胞移植的前瞻性评估(10CMSMDS-1)
核对登记原文(英文)

主要终点:A Comprehensive Source of Observational Data to assess Stem Cell Transplant · A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as: * Recipient Recover time * How recovery after transplant and other cellular therapies can be improved * Long term outcomes after transplantation and other cellular therapies * How well donors recover from collection procedure · Anually - on average
次要终点:A Comprehensive Source of Data for Marrow Toxic Injuries;Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD);Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)

研究设计怎么做的

研究类型
观察性研究
入组人数
99999999 人(预计)

关键日期

开始日期
2002-07
主要完成日期
2050-07
全部完成日期
2050-07
登记状态核实于
2025-08

联系与责任方公示信息

申办方
Center for International Blood and Marrow Transplant Research
联系电话
763 406 8087

以上邮箱 / 电话是登记库里的申办方联系方式,通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。

登记简述

研究数据库的主要目的是建立全面的观察性数据来源,用于研究造血干细胞(HSC)移植和细胞治疗。次要目的是建立全面的数据来源以研究骨髓毒性损伤。研究目标包括了解哪些因素有助于干细胞移植和细胞治疗取得良好效果:评估受者从移植或细胞治疗中的恢复情况;确定如何改善恢复;确定供者或受者遗传因素如何影响受者移植后恢复;改善不同患者群体获得移植或细胞治疗的机会;评估供者从采集程序中的恢复情况。

核对登记原文(英文)

The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies. A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries. Objectives: To learn more about what makes stem cell transplants and cellular therapies work well such as: * Determine how well recipients recover from their transplants or cellular therapy; * Determine how recovery after a transplant or cellular therapy can be improved; * Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy; * Determine how access to transplant or cellular therapy for different groups of patients can be improved; * Determine how well donors recover from the collection procedures.

登记原文与核验信息

试验登记号
NCT01166009
试验状态
招募中
试验中心(2 个)
美国 2
适应症(原文)
Autologous Stem Cell Transplantation; Allogeneic Stem Cell Transplantation; Solid Tumors; Blood Cancers; CAR-T; Gene Therapy; Non-malignant Disease