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NCT04098445 · ClinicalTrials.gov registry record
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
A clinical trial of Bronchiolitis Obliterans and Hematopoietic Stem Cell Transplant (HSCT), sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- 2,000
- Enrollment target
- 9
- Study locations
NCT04098445 is a study of Bronchiolitis Obliterans and Hematopoietic Stem Cell Transplant (HSCT) that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 2,000 participants, above the 187-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (970% higher). The trial reports 9 study locations across 8 states.
The verdict
NCT04098445, a study of Bronchiolitis Obliterans and Hematopoietic Stem Cell Transplant (HSCT), is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 9
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 187-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (970% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Bronchiolitis Obliterans appearing as the primary indexed condition, and to 0 interventions.
NCT04098445 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Washington, California, Colorado.
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.
Who is sponsoring clinical trial NCT04098445?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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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