Study of the Complications Associated With Certain Stem Cell Transplants
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 8/11/2018 |
| Start Date: | August 7, 2013 |
| End Date: | August 24, 2017 |
Natural History Study of the Complications Associated With Allogeneic Hematopoietic Stem Cell Transplantations
Background:
- The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants
(allo-HSCT) each year. Many studies already look at different problems that can follow a
transplant. But there are many types of transplants, diseases, responses, and treatments. An
organized study of this information could help researchers learn more about how often
transplant complications occur and what problems they cause. It could also lead to ideas for
future research. This study will focus on complications thought to be the most significant.
Objectives:
- To gather information on the complications that may occur after an allo-HSCT.
Eligibility:
- People over 2 years of age currently enrolled in an allo-HSCT study at NIH.
Design:
- Visits for this study will be scheduled along with primary study visits. The number of
visits will depend on the primary study schedule.
- At each visit, participants will answer questions and take physical exams.
- The same questions and physical exams will continue for as long as they are in the
primary study.
- In between visits, researchers might call participants to discuss their health. They may
also discuss the cases with the primary study doctors and other doctors. Primary
transplant study doctors will make treatment decisions.
- When participation in the primary transplant study ends, participation in this study
will also end.
- The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants
(allo-HSCT) each year. Many studies already look at different problems that can follow a
transplant. But there are many types of transplants, diseases, responses, and treatments. An
organized study of this information could help researchers learn more about how often
transplant complications occur and what problems they cause. It could also lead to ideas for
future research. This study will focus on complications thought to be the most significant.
Objectives:
- To gather information on the complications that may occur after an allo-HSCT.
Eligibility:
- People over 2 years of age currently enrolled in an allo-HSCT study at NIH.
Design:
- Visits for this study will be scheduled along with primary study visits. The number of
visits will depend on the primary study schedule.
- At each visit, participants will answer questions and take physical exams.
- The same questions and physical exams will continue for as long as they are in the
primary study.
- In between visits, researchers might call participants to discuss their health. They may
also discuss the cases with the primary study doctors and other doctors. Primary
transplant study doctors will make treatment decisions.
- When participation in the primary transplant study ends, participation in this study
will also end.
Between 80 and 100 allogeneic stem cell transplants (allo-HSCT) are performed every year at
the NIH to treat a variety of malignant and nonmalignant conditions. The current transplant
protocols at the NIH focus on research regarding the response of the underlying disease, the
development of graft versus host disease (GVHD) as well as the feasibility and safety of a
variety of transplant strategies. Many clinically significant complications are considered to
be part of the transplant process and are not studied systematically. Even when they are
studied, the diverse institute-based protocols differ on the range of complications captured
and the amount of information collected on them. This leads to knowledge gaps regarding the
incidence and risk factors for complications in the various protocols.
This exploratory natural history study involves a prospective review of the medical records
of patients actively enrolled in allo-HSCT protocols at the NIH. The study will focus on
infections and a subset of noninfectious complications identified by the transplant community
as significant causes of morbidity, mortality and cost. The cost data captured in this study
will be the cost consumed by the Clinical Center. This study does not require any sample
collection and will consist merely of data collection and optional periodic patient
examinations that will be performed in conjunction with those already scheduled by the
original transplant protocol. The prospective collection of clinical data and information
available in the medical record will allow us to determine the rates of a number of
complications in different protocols. At the completion of the study, it is expected the
investigators will be able to generate preliminary hypotheses regarding risk factors for
infection and noninfectious complications, the impact of complications on transplant costs
and the correlation between laboratory immune reconstitution (usually determined by each
transplant protocol in a variety of ways and functional immune reconstitution (frequency of
infections).
the NIH to treat a variety of malignant and nonmalignant conditions. The current transplant
protocols at the NIH focus on research regarding the response of the underlying disease, the
development of graft versus host disease (GVHD) as well as the feasibility and safety of a
variety of transplant strategies. Many clinically significant complications are considered to
be part of the transplant process and are not studied systematically. Even when they are
studied, the diverse institute-based protocols differ on the range of complications captured
and the amount of information collected on them. This leads to knowledge gaps regarding the
incidence and risk factors for complications in the various protocols.
This exploratory natural history study involves a prospective review of the medical records
of patients actively enrolled in allo-HSCT protocols at the NIH. The study will focus on
infections and a subset of noninfectious complications identified by the transplant community
as significant causes of morbidity, mortality and cost. The cost data captured in this study
will be the cost consumed by the Clinical Center. This study does not require any sample
collection and will consist merely of data collection and optional periodic patient
examinations that will be performed in conjunction with those already scheduled by the
original transplant protocol. The prospective collection of clinical data and information
available in the medical record will allow us to determine the rates of a number of
complications in different protocols. At the completion of the study, it is expected the
investigators will be able to generate preliminary hypotheses regarding risk factors for
infection and noninfectious complications, the impact of complications on transplant costs
and the correlation between laboratory immune reconstitution (usually determined by each
transplant protocol in a variety of ways and functional immune reconstitution (frequency of
infections).
- INCLUSION CRITERIA:
Subjects over the age of 2 that are actively enrolled in an allo-HSCT protocol at any NIH
institute will be eligible to participate in this study regardless of gender or medical
condition. Patients may be consented prior to and up to a week after receiving the stem
cells (Day 0 of transplant).
EXCLUSION CRITERIA:
Subjects with any condition that, in the opinion of the investigator, contraindicates
participation in the study will be excluded.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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