TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
1 other identifier
observational
2,000
1 country
9
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedStudy Start
First participant enrolled
September 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2036
July 15, 2025
July 1, 2025
5 years
September 19, 2019
July 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Lung Injury after HSCT
Participants will be assessed for lung injury at 24 months after HSCT
24 months after HSCT
Study Arms (1)
Pediatric and young adult HSCT recipients
Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT).
Eligibility Criteria
The study participants will include eligible patients undergoing allogeneic or autologous HSCT at participating institutions.
You may qualify if:
- Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.
You may not qualify if:
- Subjects over 24 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of California San Francisco
San Francisco, California, 94158, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Dana-Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine/Texas Children'S Hospital
Houston, Texas, 77030, United States
Seattle Children'S Hospital
Seattle, Washington, 98105, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Related Publications (1)
Koo J, Cooper R, Edwards SL, Lane A, Loveless SK, Strecker L, Lake KE, Myers KC, Towe C, Patti J, Walkup LL, Wikenheiser-Brokamp KA, MacMillan ML, Lacher P, Griffin T, Tekman M, Cisneros GS, Wu K, Zinter MS, Urrego FA, Baker KS, Abts MF, Ballard S, Freedman JL, Caraballo A, Young LR, Josephson MB, Allen JL, Camburn DM, Doherty EE, Azamian MS, Arredondo M, Silva-Carmona M, Lehmann LE, Wong W, Gaffin JM, McAlpine W, Li M, Goldfarb SB, Woods JC, Davies SM. High Prevalence of Abnormal Baseline Lung Function in Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients: A Report from the TRANSPIRE Study. Pediatr Blood Cancer. 2025 Oct;72(10):e31916. doi: 10.1002/pbc.31916. Epub 2025 Jul 21.
PMID: 40692216DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stella Davies, MBBS, PhD, MRCP
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 23, 2019
Study Start
September 8, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2036
Last Updated
July 15, 2025
Record last verified: 2025-07