Actively Recruiting

Age: 5Years - 70Years
All Genders
ID06093867

A Prospective Approach for the Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-04-09

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

N

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

N

National Institutes of Health Clinical Center (CC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating ways to detect early signs of lung inflammation and injury in people who have received allogeneic hematopoietic stem cell transplantation (HSCT). This procedure involves receiving stem cells from a donor and is used to treat blood cancers and immune system disorders. The study aims to find better methods to identify lung problems caused by the immune system attacking healthy lung cells after HSCT. Participants will undergo several tests before and regularly for two years after their HSCT. These tests include ultra-low dose CT scans to image the lungs, bronchoscopy with lavage to collect lung cells and fluids while sedated, blood tests every 2 to 4 weeks, and pulmonary function tests including a 6-minute walk test. These assessments will help researchers monitor lung health and detect inflammation early. During the study, participants will have repeated imaging, lung fluid sampling, blood draws, and breathing tests to track lung function and inflammation. The primary goal is to identify lung injury earlier using chest imaging and bronchoscopy. The study will also analyze lung and blood samples to understand the biological changes linked to lung problems after HSCT. The total observation period for participants is 30 months, allowing detailed monitoring of lung health over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to comply with all study procedures and available for the entire study duration
  • Male or female, aged 5 to 70 years
  • Scheduled to receive allogeneic HSCT for hematologic malignancy, blood, or immune system disorders at the NIH Clinical Center
  • Able to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • For women of reproductive potential, must have a negative serum pregnancy test during screening
  • Women of reproductive potential defined as sexually mature women without hysterectomy, bilateral oophorectomy, tubal occlusion, or natural menopause for at least one year

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 30 months

Participants undergo sequential chest imaging and bronchoalveolar lavage (BAL) measures to detect early lung injury related to infection or alloreactive syndromes after allogeneic hematopoietic stem cell transplantation (HSCT).

Regular assessments including chest tomography and bronchoscopy with lavage

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

G

Gloria Y Pastor, R.N.

A

Anthony F Suffredini, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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