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NCT04098445 Clinical Trial

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

Bronchiolitis Obliterans Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04098445
Other study ID # 2019-0001C
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2021
Est. completion date September 2036

Study information
Verified date January 2024
Source Children's Hospital Medical Center, Cincinnati
Contact Stephanie Edwards, BSN, RN
Phone 513-636-9292
Email StephanieL.Edwards@cchmc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date September 2036
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Years
Eligibility Inclusion Criteria: - Subjects = 24 years of age undergoing allogeneic or autologous HSCT. Exclusion Criteria: - Subjects over 24 years of age.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Dana-Farber Cancer Institute/Boston Children's Hospital Boston Massachusetts
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Baylor College of Medicine/Texas Children'S Hospital Houston Texas
United States University of Minnesota Minneapolis Minnesota
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of California San Francisco San Francisco California
United States Fred Hutchinson Cancer Center Seattle Washington
United States Seattle Children'S Hospital Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Lung Injury after HSCT Participants will be assessed for lung injury at 24 months after HSCT 24 months after HSCT
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