Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06093867
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
A Prospective Approach for the Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2025-08-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
Stem cell transplants (called hematopoietic stem cell transplantation, or HSCT) are used to treat various diseases. But when the cells for this procedure are donated by someone other than the person who receives the HSCT ( allogeneic HSCT ), the recipient has an increased risk of lung inflammation and scarring. This happens when their immune cells attack healthy lung cells. In this natural history study, researchers will look for the best ways to detect developing lung inflammations earlier after an HSCT.
Objective:
To see if certain tests can detect early signs of lung inflammation in people after HSCT.
Eligibility:
People aged 5 to 70 years who will have HSCT as part of another NIH study.
Design:
Participants will undergo these tests prior to their HSCT. These tests will then be repeated regularly for 2 years:
Ultra-low dose computed tomography (CT) scans. Participants will lie on a table that slides through a machine; the machine uses X-rays to get pictures of the inside of the body. This type of scan uses less radiation than normal CT scans.
Bronchoscopy with lavage: Participants will be sedated. A flexible tube will be inserted through the mouth and into the airways. Salt water will be squirted into the lung, then sucked out to collect cells and fluids from the lung. Another tube with a camera may be inserted into the airways to take pictures.
Blood tests. Blood will be drawn every 2 to 4 weeks.
Pulmonary function tests. Participants will breathe into a machine to test their lung function. They will see how far they can walk in 6 minutes.
Stem cell transplants (called hematopoietic stem cell transplantation, or HSCT) are used to treat various diseases. But when the cells for this procedure are donated by someone other than the person who receives the HSCT ( allogeneic HSCT ), the recipient has an increased risk of lung inflammation and scarring. This happens when their immune cells attack healthy lung cells. In this natural history study, researchers will look for the best ways to detect developing lung inflammations earlier after an HSCT.
Objective:
To see if certain tests can detect early signs of lung inflammation in people after HSCT.
Eligibility:
People aged 5 to 70 years who will have HSCT as part of another NIH study.
Design:
Participants will undergo these tests prior to their HSCT. These tests will then be repeated regularly for 2 years:
Ultra-low dose computed tomography (CT) scans. Participants will lie on a table that slides through a machine; the machine uses X-rays to get pictures of the inside of the body. This type of scan uses less radiation than normal CT scans.
Bronchoscopy with lavage: Participants will be sedated. A flexible tube will be inserted through the mouth and into the airways. Salt water will be squirted into the lung, then sucked out to collect cells and fluids from the lung. Another tube with a camera may be inserted into the airways to take pictures.
Blood tests. Blood will be drawn every 2 to 4 weeks.
Pulmonary function tests. Participants will breathe into a machine to test their lung function. They will see how far they can walk in 6 minutes.
Detailed Description:
Study Description:
The primary goal of this proposal is to use preemptive pulmonary imaging, biomarker measurement with surveillance bronchoscopy to improve the early detection of inflammatory injury after allogeneic hematopoietic stem cell transplantation (HSCT). These data may provide early identification of patients at risk for infectious and noninfectious lung diseases and accelerate the development of targeted therapies.
Objectives:
Primary Objective:
To use preemptive assessments with sequential chest imaging and bronchoalveolar lavage (BAL) measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with hematopoietic stem cell transplantation
Secondary Objectives:
To use high density proteomic, transcriptomic and metagenomic analysis of specimens from the lung and blood to define mechanisms of altered lung function associated with HSCT.
Endpoints:
Primary Endpoint: To assess whether surveillance chest tomography and bronchoscopy with lavage detects incipient lung infection and noninfectious lung injury prior to and following HSCT
Secondary Endpoints: To determine if biomarkers from surveillance proteomic, transcriptomic or metagenomic analysis will provide early identification of lung injury prior to the development chronic progressive and irreversible lung disease
The primary goal of this proposal is to use preemptive pulmonary imaging, biomarker measurement with surveillance bronchoscopy to improve the early detection of inflammatory injury after allogeneic hematopoietic stem cell transplantation (HSCT). These data may provide early identification of patients at risk for infectious and noninfectious lung diseases and accelerate the development of targeted therapies.
Objectives:
Primary Objective:
To use preemptive assessments with sequential chest imaging and bronchoalveolar lavage (BAL) measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with hematopoietic stem cell transplantation
Secondary Objectives:
To use high density proteomic, transcriptomic and metagenomic analysis of specimens from the lung and blood to define mechanisms of altered lung function associated with HSCT.
Endpoints:
Primary Endpoint: To assess whether surveillance chest tomography and bronchoscopy with lavage detects incipient lung infection and noninfectious lung injury prior to and following HSCT
Secondary Endpoints: To determine if biomarkers from surveillance proteomic, transcriptomic or metagenomic analysis will provide early identification of lung injury prior to the development chronic progressive and irreversible lung disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 001742-H | None | None | View |