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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-08

Study Completion Date

2023-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection

NCT02926612

Lower Respiratory Tract Infections

UNKNOWN

Prospective Surveillance For Respiratory Virus Infections In Children Undergoing Hematopoietic Stem Cell Transplantation

NCT00667303

Respiratory Virus Infections

COMPLETED

Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation

NCT00009711

Long-term Effects Secondary to Cancer Therapy in Children Pulmonary Complications

COMPLETED

Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients

NCT01135355

Blood Stem Cell Transplant Failure

TERMINATED

Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

NCT02032381

Bone Marrow Transplant Infection Bronchiolitis Obliterans Chronic Respiratory Insufficiency +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure Respiratory Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subgroup 1

Composed of HCT patients with respiratory failure requiring intubation and mechanical ventilation.

No interventions assigned to this group

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.

No interventions assigned to this group

Subgroup 3

Composed of chimeric antigen T-cell receptor infusion recipients who have respiratory failure requiring intubation and mechanical ventilation.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No