Study of the Complications Associated With Certain Stem Cell Transplants

NCT01919099 | Completed

• 2 other identifiers: 13017713-I-0177
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Transplant Infections; Post-Transplant Renal Insufficiency; Post-Transplant Pulmonary Complications

Keywords

Post-Transplant Infection; Post-Transplant Bacteremia; Post-Transplant Virus; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

  Every few years or as requested by the clinical center or investigators.

Study Arms (1)

Post-transplant

Patients receiving allogenic stem cell transplants at the NIH CC

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From NIH transplant protocols

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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, Munoz 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. doi: 10.1086/588660.

  PMID: 18462102 BACKGROUND

• Seo S, Campbell AP, Xie H, Chien JW, Leisenring WM, Englund JA, Boeckh M. Outcome of respiratory syncytial virus lower respiratory tract disease in hematopoietic cell transplant recipients receiving aerosolized ribavirin: significance of stem cell source and oxygen requirement. Biol Blood Marrow Transplant. 2013 Apr;19(4):589-96. doi: 10.1016/j.bbmt.2012.12.019. Epub 2013 Jan 5.

  PMID: 23298855 BACKGROUND

• Azoulay E, Bergeron A, Chevret S, Bele N, Schlemmer B, Menotti J. Polymerase chain reaction for diagnosing pneumocystis pneumonia in non-HIV immunocompromised patients with pulmonary infiltrates. Chest. 2009 Mar;135(3):655-661. doi: 10.1378/chest.08-1309.

  PMID: 19265086 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Christa S Zerbe, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 8, 2013
• Study Start: July 31, 2013
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

US (1)