A Database Study for Hematopoietic Stem Cell Transplantation and Marrow Injuries
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Purpose
The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation.
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 work well, such as determining the following:
- how well recipients recover from their transplant
- how recovery after a transplant can be improved
- how access to transplant for different groups of patients can be improved
- how well donors recover from the collection procedures
| Condition |
|---|
|
Autologous Stem Cell Transplantation Allogeneic Stem Cell Transplantation Solid Tumors Blood Cancers |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Protocol For A Research Database For Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries |
- A Comprehensive Source of Observational Data to assess Stem Cell Transplant [ Time Frame: Anually - on average ] [ Designated as safety issue: No ]
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 can be improved
- Long term outcomes after transplantation
- How well donors recover from collection procedure
- A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 99999999 |
| Study Start Date: | July 2002 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Recipients and Donors that are involved with a stem cell transplantation process.
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.
Contacts and Locations| Contact: Marie Matlack | 612-627-5811 | mmatlack@nmdp.org |
| Contact: Mandi Proue | mproue@nmdp.org |
| United States, Minnesota | |
| Center for International Blood and Marrow Transplant Research | Recruiting |
| Minneapolis, Minnesota, United States, 55413 | |
| Principal Investigator: | Douglas Rizzo, M.D.,M.S | Center for International Blood and Marrow Transplant Research |
More Information
No publications provided
| Responsible Party: | Center for International Blood and Marrow Transplant Research |
| ClinicalTrials.gov Identifier: | NCT01166009 History of Changes |
| Obsolete Identifiers: | NCT01160497 |
| Other Study ID Numbers: | NMDP IRB-1999-0021 |
| Study First Received: | July 16, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Center for International Blood and Marrow Transplant Research:
|
Data Collection CIBMTR NMDP Stem Cell Transplantation |
Additional relevant MeSH terms:
|
Hematologic Neoplasms Neoplasms by Site Neoplasms Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013