Long-term observation of lung injury in children after stem cell transplants
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
This study looks at children who have had stem cell transplants to see how often they develop lung problems and how these issues affect their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 24 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 9 sites (San Francisco, California and 8 other locations) |
| Trial ID | NCT04098445 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pediatric patients who have undergone hematopoietic stem cell transplantation (HSCT) to assess the incidence and impact of pulmonary complications such as diffuse alveolar hemorrhage and bronchiolitis obliterans. It aims to fill critical knowledge gaps regarding the etiology and optimal treatment of these complications, which can significantly affect survival and quality of life. The study will involve multiple institutions and will track patients over time to improve diagnosis and treatment strategies for lung injuries associated with HSCT.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 24 years or younger who are undergoing allogeneic or autologous HSCT.
Not a fit: Patients over the age of 24 will not benefit from this study as they do not meet the eligibility criteria.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and management of lung complications in children undergoing HSCT, ultimately improving their survival and quality of life.
How similar studies have performed: While there is ongoing research into pulmonary complications in HSCT patients, this specific longitudinal approach in a pediatric cohort is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT. Exclusion Criteria: * Subjects over 24 years of age.
Where this trial is running
San Francisco, California and 8 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Dana-Farber Cancer Institute/Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Baylor College of Medicine/Texas Children'S Hospital — Houston, Texas, United States (Recruiting)
- Seattle Children'S Hospital — Seattle, Washington, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Stella Davies, MBBS, PhD, MRCP — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Stephanie Edwards, BSN, RN
- Email: StephanieL.Edwards@cchmc.org
- Phone: 513-636-9292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.