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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
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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 (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

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Pediatric and young adult HSCT recipients
Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT).



Primary Outcome Measures :
  1. Incidence of Lung Injury after HSCT [ Time Frame: 24 months after HSCT ]
    Participants will be assessed for lung injury at 24 months after HSCT



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Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study participants will include eligible patients undergoing allogeneic or autologous HSCT at participating institutions.
Criteria

Inclusion Criteria:

  • Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.

Exclusion Criteria:

  • Subjects over 24 years of age.

Information from the National Library of Medicine

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


Contacts
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Contact: Sara Loveless, BSN, RN 513-803-7656 Sara.Loveless@cchmc.org

Locations
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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         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04098445    
Other Study ID Numbers: 2019-0001
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Lung Injury
Bronchiolitis Obliterans
Pneumonia
Lung Diseases, Interstitial
Thrombotic Microangiopathies
Hemorrhage
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Thoracic Injuries
Wounds and Injuries
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases