Study of the Complications Associated With Certain Stem Cell Transplants

March 20, 2024 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From NIH transplant protocols

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Post-transplant
Patients receiving allogenic stem cell transplants at the NIH CC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterize the infectious and noninfectious complications associated with allo-HSCT, including incidence, clinical course, cost to the Clinical Center and distribution within each NIH intramural transplant protocol
Time Frame: Every few years or as requested by the clinical center or investigators.
Every few years or as requested by the clinical center or investigators.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Christa S Zerbe, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2013

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimated)

August 8, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130177
  • 13-I-0177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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