Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-70
SponsorNational Heart, Lung, and Blood Institute (NHLBI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stated willingness to comply with all study procedures and availability for the duration of the study.

Male or female, aged 5 - 70 years of age

Are to be treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorders at the NIH Clinical Center.

Ability of subject to understand and the willingness to sign a written informed consent document.

Disqualifiers

None

Trial population

Men or women, 18 - 70 years of age \& children 5 - 17 years , who are being treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorder at the NIH Clinical Center

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: allogeneic HSCT

Trial outcomes

Primary outcomes

1

To use preemptive assessments with sequential chest imaging and BAL measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with HSCT.

To assess whether surveillance chest tomography and bronchoscopy with lavage detects incipient lung infection and noninfectious lung injury prior to and following HSCT

Time frame
30 months

Secondary outcomes

1

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.

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

Time frame
30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Heart, Lung, and Blood Institute (NHLBI)

Lead sponsor

National Institutes of Health Clinical Center (CC)

Collaborator