Study of the Complications Associated With Certain Stem Cell Transplants

This study is currently recruiting participants.
Verified July 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01919099
First received: August 7, 2013
Last updated: March 14, 2014
Last verified: July 2013
  Purpose

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.

Condition
Stem Cell Transplantation, Hematopoietic
Complications
Infection

Study Type: Observational
Official Title: Natural History Study of the Complications Associated With Allogeneic Hematopoietic Stem Cell Transplantations

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Infections [ Time Frame: before day 100 and yearly thereafter ] [ Designated as safety issue: No ]
  • Pulmonary complications [ Time Frame: before day 100 and yearly thereafter ] [ Designated as safety issue: No ]
  • Renal complications [ Time Frame: before day 100 and yearly thereafter ] [ Designated as safety issue: No ]
  • Hepatic complications [ Time Frame: before day 100 and yearly thereafter ] [ Designated as safety issue: No ]
  • Cardiac complications [ Time Frame: before day 100 and yearly thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2013
Estimated Study Completion Date: June 2028
Estimated Primary Completion Date: June 2028 (Final data collection date for primary outcome measure)
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 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).

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Subjects over the age of 2 that are actively enrolled in an allo-HSCT protocol (and before they have allo-HSCT) at any NIH institute will be eligible to participate in this study regardless of gender or medical condition.

EXCLUSION CRITERIA:

Subjects with any condition that, in the opinion of the investigator, contraindicates participation in the study will be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01919099

Contacts
Contact: Theresa D Jerussi, P.A.-C (301) 496-8993 jerussitd@cc.nih.gov
Contact: Juan C Gea-Banacloche, M.D. (301) 435-2326 banacloj@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Juan C Gea-Banacloche, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Muñoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21.

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01919099     History of Changes
Other Study ID Numbers: 130177, 13-I-0177
Study First Received: August 7, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Transplantation Costs
Risk Factors
Transplant Infections

ClinicalTrials.gov processed this record on April 17, 2014