CIBMTR Research Database
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ClinicalTrials.gov Identifier: NCT01166009 |
Recruitment Status :
Recruiting
First Posted : July 20, 2010
Last Update Posted : January 23, 2023
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Sponsor:
Center for International Blood and Marrow Transplant Research
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
Tracking Information | |||||
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First Submitted Date | July 16, 2010 | ||||
First Posted Date | July 20, 2010 | ||||
Last Update Posted Date | January 23, 2023 | ||||
Study Start Date | July 2002 | ||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
A Comprehensive Source of Observational Data to assess Stem Cell Transplant [ Time Frame: Anually - on average ] A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as:
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Original Primary Outcome Measures |
A Comprehensive Source of Observational Data to assess Stem Cell Transplant [ Time Frame: Anually - on average ] A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as:
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ] | ||||
Current Other Pre-specified Outcome Measures |
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage [ Time Frame: annually - on average ] This study is the main protocol for the following two sub studies. Details for these sub-studies are found under separate NCT numbers.
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Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | CIBMTR Research Database | ||||
Official Title | Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries | ||||
Brief Summary | 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:
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Recipients and Donors that are involved with stem cell transplantation, other cellular therapies, and gene therapies. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Atallah E, Logan B, Chen M, Cutler C, Deeg J, Jacoby M, Champlin R, Nishihori T, Confer D, Gajewski J, Farnia S, Greenberg P, Warlick E, Weisdorf D, Saber W, Horowitz MM, Rizzo JD. Comparison of Patient Age Groups in Transplantation for Myelodysplastic Syndrome: The Medicare Coverage With Evidence Development Study. JAMA Oncol. 2020 Apr 1;6(4):486-493. doi: 10.1001/jamaoncol.2019.5140. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
99999999 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 2025 | ||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Eligibility to Participate in the Research Database Recipient Eligibility Criteria:
Individual with Marrow Toxic Injury Eligibility Criteria:
Unrelated Donor Eligibility Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01166009 | ||||
Other Study ID Numbers | NMDP IRB-1999-0021 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | Center for International Blood and Marrow Transplant Research | ||||
Original Responsible Party | J. Douglas Rizzo, M.D.,M.S, Center for International Blood and Marrow Transplant Research | ||||
Current Study Sponsor | Center for International Blood and Marrow Transplant Research | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Center for International Blood and Marrow Transplant Research | ||||
Verification Date | January 2023 |