Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients

Respiratory Failure Clinical Trial

Official title:

Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355780
• Other study ID #: HCTALI
• Status: Completed
• Start date: January 8, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

• To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases.

• To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure.

• To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases.

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Participant is age 0 to 21 years old

• Participant has acute respiratory failure due to primary pulmonary disease and is expected to receive invasive mechanical ventilation for more than 48 hours

Exclusion Criteria:

• The primary etiology of respiratory failure is not related to primary pulmonary disease

• Aspiration is present

• The participant has a tracheostomy

• If the patient has undergone HCT, they are more than 100 days removed from HCT

• Has a diagnosis of severe combined immunodeficiency syndrome (SCIDS)

• The primary on-service team feels obtaining a study sample would be unsafe for any reason.

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	: 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
Secondary	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

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital