TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
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|ClinicalTrials.gov Identifier: NCT04098445|
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
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 (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT). 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.
|Condition or disease|
|Hematopoietic Stem Cell Transplant (HSCT) Diffuse Alveolar Hemorrhage Thrombotic Microangiopathies Interstitial Pneumonitis Bronchiolitis Obliterans|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||September 2035|
Pediatric and young adult HSCT recipients
Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT).
- Incidence of Lung Injury after HSCT [ Time Frame: 24 months after HSCT ]Participants will be assessed for lung injury at 24 months after HSCT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098445
|Contact: Sara Loveless, BSN, RN||513-803-7656||Sara.Loveless@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Contact: Sara Loveless, BSN, RN 513-803-7656 Sara.Loveless@cchmc.org|
|Principal Investigator: Stella Davies, MBBS, PhD, MRCP|
|Principal Investigator: Jason Woods, PhD|