Last updated on June 2013

Submission of Stem Cell Transplant Data to CIBMTR and NMDP


Brief description of study

Background: - A federal government mandate requires stem cell transplant centers to collect and maintain in a database a minimum of information regarding transplant recipients and their donors. - The National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Research (CIBMTR) maintain an extensive database of medical information on transplant donors and recipients and conducts research using this information. - Information collected under this study will be submitted to NMDP/CIBMTR in response to the federal mandate. 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 Eligibility: - Patients enrolled in an NIH stem cell transplant protocol. Design: - Patients are asked to give informed consent to participate in the study before starting pre-transplant conditioning. - Donors are asked to give informed consent to participate before starting preparation for stem cell collection begins. - Patients and donors who do not wish to participate will still have a minimum set of data submitted, as required by law, but the information obtained will not be used in research.

Detailed Study Description

Background: - In 2005, the United States Congress legislated that outcome data would be collected on all patients who have been recipients of a stem cell therapeutics product (including bone marrow, cord blood, or other such product) from a donor. The Health Services and Resources Administration (HRSA) awarded the contract for this Stem Cell Therapeutic Outcomes Database (SCTOD) to the Center for International Blood and Marrow Transplantation (CIBMTR). The CIBMTR is thus responsible for the administration of this activity and collection and analysis of the data. The CIBMTR was established in 2004 as an affiliation between the National Marrow Donor Program (NMDP) and the Medical College of Wisconsin. - NCI - ETIB and POB, in order to comply with the SCTOD requirements, will participate in the CIBMTR Outcomes Data Reporting process for all autologous and related allogeneic hematopoietic cell therapy recipients and donors. Patients receiving unrelated donor cell therapies will participate in a separate data collection protocol designed to satisfy the requirements for participation as an NMDP transplant center as well as the SCTOD reporting. Objectives: - To meet the reporting requirements of the Stem Cell Therapeutic Outcomes Database. Eligibility: - All patients receiving autologous or related allogeneic hematopoietic stem cell transplants will be eligible regardless of age, diagnosis, or disease status. Design and Modifications from CIBMTR protocol: - Patients will be consented prior to the start of their pre-transplant conditioning regimen. - Related donors will be consented prior to the start of their mobilization or, if no mobilization, prior to the date of cell collection. - Patients and donors who do not wish to participate will still have a minimum set of data submitted, as required by law. However, this data will not be used in research. - For privacy concerns, the following data will not be collected or reported: Social Security Number (SSN), Mother's Maiden Name, Country of birth, Median household income, Education and Occupation. This data may be omitted without affecting compliance with the SCTOD. All other demographic data collected at NIH will be stored separate from the research records in a locked cabinet accessible only to those with roles directly related to reporting the data.

Clinical Study Identifier: NCT00923585

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