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

NCT06093867 | Recruiting

• 2 other identifiers: 10001742001742-H
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Keywords

allogeneic hematopoietic stem cell transplantation (HSCT); early detection of inflammatory injury

Outcome Measures

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

  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.

  30 months

Study Arms (1)

allogeneic HSCT

Up to 30 men or women, 18 - 70 years of age, who are being treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorder at the NIH Clinical CenterUp to 10 children 5 - 17 years of age who are being treated with allogeneic HSCT for a hematologic malignancies, blood, or immune system disorder at the NIH Clinical CenterNIH Clinical Center

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• \. Pregnancy or lactation
• a. HSCT is not available to pregnant women or lactating women in the intramural program. For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Anthony F Suffredini, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Y Pastor, R.N.

CONTACT

(301) 402-3484; gloria.pastor@nih.gov

Anthony F Suffredini, M.D.

CONTACT

(301) 496-9320; asuffredini@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 23, 2023
• Study Start: April 8, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)