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| ID | Type | Description | Link |
|---|---|---|---|
| 7R01AI159684-02 | U.S. NIH Grant/Contract | View source | |
| NCI-2022-08554 | Other Identifier | National Institute of Health |
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| Name | Class |
|---|---|
| St. Jude Children's Research Hospital | OTHER |
| Seattle Children's Hospital | OTHER |
| Children's Hospital at Montefiore | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) |
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The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT).
Primary Objective
To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors.
Secondary Objectives:
The investigators will collect a nasal swab and blood sample from the participant when the participant is enrolled on the study and if the participant develops a RVI in the first year after transplant. The investigators will collect a blood sample 100 days after the participant's transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants developing a RVI within one-year post transplant. | Prevalence is estimated as the proportion of HCT or SOT participants with a positive PCR pre-transplant screen who develop any RVI within one year post transplant. A 95% confidence interval will be provided. | Baseline through 1-year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant | Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of pre-transplant quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from pre-transplant to year one post-transplant | 1 year |
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Recipient Inclusion Criteria
Less than 18 years at the time of anticipated transplant
Participant meets one of the following criteria:
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 Inclusion Criteria
Exclusion Criteria:
Recipient Exclusion Criteria
None
Donor Exclusion Criteria
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All participants who meet eligibility criteria and consent to enrollment on the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Maron, MD | Contact | 866-278-5833 | referralinfo@stjude.org | |
| William J. Steinbach, MD | Contact | 501-364-5262 | wsteinbach@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gabriela Maron, MD | St. Jude Children's Research Hospital | Principal Investigator |
| William J. Steinbach, MD | Arkansas Children's Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham's (UAB) | Recruiting | Birmingham | Alabama | 35294 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| NIH |
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| Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant. | Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of Day 100 quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from Day 100 to year one post-transplant | Day +100 through 1-year post-transplant |
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States |
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| Children's National Medical | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| University if Miami | Recruiting | Miami | Florida | 33146 | United States |
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| Emory and Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Chicago Medicine Comer Children's Hospital | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| C.S. Mott Children's Hospital | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Children's Hospital of Michigan | Recruiting | Detroit | Michigan | 48201 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63105 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| The Children's Hospital at Montefiore | Recruiting | The Bronx | New York | 10467 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Le Bonheur Children's Hospital | Recruiting | Memphis | Tennessee | 38103 | United States |
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| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
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| UT Le Bonheur | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Cook Children's | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| MD Anderson Center Center | Recruiting | Houston | Texas | 77030 | United States |
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| UTHealth Houston | Recruiting | Houston | Texas | 77225-0036 | United States |
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| Seattle Childrens | Recruiting | Seattle | Washington | 98105 | United States |
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| Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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