RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-08
Study Completion:2036-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04098445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.
  1. * Subjects over 24 years of age.

Contacts and Locations

Study Contact

Stephanie Edwards, BSN, RN
CONTACT
513-636-9292
StephanieL.Edwards@cchmc.org

Principal Investigator

Stella Davies, MBBS, PhD, MRCP
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

University of California San Francisco
San Francisco, California, 94158
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

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Stella Davies, MBBS, PhD, MRCP, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-08
Study Completion Date2036-09

Study Record Updates

Study Start Date2021-09-08
Study Completion Date2036-09

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic Stem Cell Transplant (HSCT)
  • Diffuse Alveolar Hemorrhage
  • Thrombotic Microangiopathies
  • Interstitial Pneumonitis
  • Bronchiolitis Obliterans