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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | May 25, 2000 | ||||||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||||||
| Start Date ICMJE | January 1989 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||
| Change History | Complete list of historical versions of study NCT00005730 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | National Marrow Donor Program (NMDP) | ||||||||||||||||
| Official Title ICMJE | |||||||||||||||||
| Brief Summary | To serve as a focal point for bone-marrow research. |
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| Detailed Description | BACKGROUND: In 1986, the Department of the Navy initiated the National Bone Marrow Donor Registry. Because the support of a National Bone Marrow Donor Registry was not very closely related to the Navy's primary missions, in 1989 the management of the contract for the program was transferred by the Congress from the Navy to the NHLBI. By 1989, bone marrow transplantation had become an effective and accepted treatment for an increasing number of diseases of the bone marrow and the immune system. Until only a few years prior to 1989, most marrow donors were siblings, carefully matched for HLA (tissue) antigens. Since only a small proportion of candidates for a bone marrow transplant have matched brothers or sisters, additional family members were tried as donors. These included parents, children, slightly mismatched siblings, and other relatives. Even with the broadening of the bone marrow donor source, no more than 30-40 percent of patients with diseases amenable to marrow transplant therapy had available donors. Improved results with these selectively mismatched relatives and a distinct need to provide appropriate treatment for more patients led to trials with unrelated, HLA-matched community volunteers as bone marrow donors. By 1989, research had progressed to the point where transplants from such unrelated donors were nearly as successful as those from matched siblings, when stratified by disease status and risk parameters. In 1989, 20 to 25 percent of patients for whom a formal donor search was initiated received a transplant. This was expected to increase substantially. DESIGN NARRATIVE: The program was established by the Department of the Navy in 1986 and transferred to the NHLBI in 1989. The purpose was to develop and maintain a registry of individuals willing to donate bone marrow for patients in need of transplants, to facilitate marrow transplants by serving as a coordinating and communications center for a network of donor, collection and transplant centers in the United States and internationally, and to facilitate research into the efficacy of unrelated donor marrow transplants. In 1992, the program was enlarged to support a limited number of demonstration projects to develop, implement, and evaluate innovative models for minority marrow donor recruitment. In 1995, the NMDP was transferred to the Health Resources and Services Administration (HRSA), although NHLBI provided funds in this year. |
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| Study Phase | |||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Screening | ||||||||||||||||
| Condition ICMJE | Bone Marrow Transplantation | ||||||||||||||||
| Intervention ICMJE | |||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||
| Completion Date | December 1995 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||||||||||||||
| Ages | |||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | |||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00005730 | ||||||||||||||||
| Responsible Party | |||||||||||||||||
| Study ID Numbers ICMJE | 4939 | ||||||||||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||
| Verification Date | March 2005 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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