Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
NCT ID: NCT05550298
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2022-12-13
2029-08-31
Brief Summary
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Primary Objective
To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors.
Secondary Objectives:
* To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors.
* To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hematopoietic Cell Transplantation (HCT)
Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone HCT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.
No interventions assigned to this group
Solid Organ Transplant (SOT)
Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone SOT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant meets one of the following criteria:
1. scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
2. Scheduled to or received solid organ transplant within 7 days before or after enrollment
* Participant is receiving care at the time of enrollment at one of the study participating institutions.
* Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent.
* Donor for HCT recipient enrolled on the VIPER study.
* Willing and able to provide informed consent.
Exclusion Criteria
* Is not an HCT donor for a participant enrolled on the VIPER study.
* Not available to provide pre-transplant research blood sample.
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Seattle Children's Hospital
OTHER
The Children's Hospital at Montefiore
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Gabriela Maron, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
William J. Steinbach, MD
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Hospital Research Institute
Locations
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University of Alabama at Birmingham's (UAB)
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's National Medical
Washington D.C., District of Columbia, United States
University if Miami
Miami, Florida, United States
Emory and Children's Healthcare of Atlanta
Atlanta, Georgia, United States
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
UT Le Bonheur
Memphis, Tennessee, United States
Cook Children's
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
MD Anderson Center Center
Houston, Texas, United States
UTHealth Houston
Houston, Texas, United States
Seattle Childrens
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Victoria Statler, MD
Role: primary
Masako Shimamura, MD
Role: primary
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2022-08554
Identifier Type: OTHER
Identifier Source: secondary_id
VIPER
Identifier Type: -
Identifier Source: org_study_id
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