Bethesda, Maryland 20892

  • Blood Cancers

Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00923585


Primary Contact:

Principal Investigator
Ronald E Gress, M.D.
National Cancer Institute (NCI)

Zetta A Blacklock-Schuver, R.N.
Phone: (301) 451-6569
Email: bblacklock@mail.nih.gov


Backup Contact:

Email: gressr@mail.nih.gov
Ronald E Gress, M.D.
Phone: (301) 496-1791


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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