CIBMTR Research Database
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autologous Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Solid Tumors, Blood Cancers. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Overview
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.
Primary outcome measures
- A Comprehensive Source of Observational Data to assess Stem Cell Transplant [Time frame: Anually - on average]
Secondary outcome measures (3)
- A Comprehensive Source of Data for Marrow Toxic Injuries [Time frame: anually- on average]
- Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD) [Time frame: annually - on average]
- Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1) [Time frame: annually - on average]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Center for International Blood and Marrow Transplant Research — Minneapolis
- Medical College of Wisconsin — Milwaukee
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. PMID 31830234
Identifiers
NCT: NCT01166009 · NMDP IRB-2002-0063