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This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure.
Primary Objective
To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients.
Secondary Objectives
Exploratory Objectives
To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site.
To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.
This study involves a Tracheal aspirate, Bronchoalveolar lavage (BAL), and blood samples. The tracheal aspirates and blood samples will be obtained within 24 hours of intubation, then twice more every 3 -4 days, and then once a week until the patient is extubated. If the primary treatment team performs bronchoscopy with BAL, then an aliquot of residual BAL fluid will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subgroup 1 | Composed of HCT patients with respiratory failure requiring intubation and mechanical ventilation. | ||
| Subgroup 2 | Composed of oncology patients (solid tumor or leukemia patients) who have not undergone HCT and who have respiratory failure requiring intubation and mechanical ventilation. | ||
| Subgroup 3 | Composed of chimeric antigen T-cell receptor infusion recipients who have respiratory failure requiring intubation and mechanical ventilation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of performing single cell gene expression analyses on tracheal aspirates | Feasibility is a qualitative binary outcome (Yes and No), based on the success of recovery of more than 100,000 live cells from a tracheal aspirate and blood sample from five of the first ten allo HCT patients enrolled on the study protocol. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Success of distinguishing unique immunopathology for each of the early post-HCT lung diseases | This is a qualitative binary outcome (Yes/No) by applying single cell gene expression analyses to cells from tracheal aspirates and blood of patients with post-HCT lung diseases. With visualization techniques, a call of success (Yes/No) will be made. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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All participants who meet eligibility criteria and consent to enrollment on the study.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Flerlage, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | 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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| : Difference of cell composition and activation states between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure. | This is a qualitative binary outcome (different vs not different) obtained from visualization. | 4 years |
| Whether allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases. | This is a qualitative binary endpoint assessed by visualization. | 4 years |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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