TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 24
Healthy Volunteers: f
View:

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

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Massachusetts
Dana-Farber Cancer Institute/Boston Children's Hospital
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Baylor College of Medicine/Texas Children'S Hospital
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Seattle Children'S Hospital
RECRUITING
Seattle
Contact Information
Primary
Stephanie Edwards, BSN, RN
StephanieL.Edwards@cchmc.org
513-636-9292
Time Frame
Start Date: 2021-09-08
Estimated Completion Date: 2036-09
Participants
Target number of participants: 2000
Treatments
Pediatric and young adult HSCT recipients
Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT).
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov

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