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TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
NCT04098445 · View on ClinicalTrials.gov ↗
Study Summary
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.
Conditions Studied
Study Locations (9)
Washington
- Seattle Children'S Hospital — Seattle
- Fred Hutchinson Cancer Center — Seattle
California
- University of California San Francisco — San Francisco
Colorado
- Children's Hospital Colorado — Aurora
Massachusetts
- Dana-Farber Cancer Institute/Boston Children's Hospital — Boston
Minnesota
- University of Minnesota — Minneapolis
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Texas
- Baylor College of Medicine/Texas Children'S Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2036-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04098445
The ClinicalTrials.gov registry entry for NCT04098445 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Bronchiolitis Obliterans appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04098445 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Washington, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04098445 about?
NCT04098445 is a clinical study titled "TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients". Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infectio...
What is the current status of trial NCT04098445?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2021-09-08. Estimated completion is 2036-09.
What conditions does trial NCT04098445 study?
This clinical trial studies the following conditions: Bronchiolitis Obliterans, Hematopoietic Stem Cell Transplant (HSCT), Thrombotic Microangiopathies, Diffuse Alveolar Hemorrhage, Interstitial Pneumonitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04098445?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04098445 being conducted?
This trial has 9 study locations across California, Colorado, Massachusetts, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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