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

Part of paid clinical trials in San Francisco, California.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04098445
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 24 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 8, 2021
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2036

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Pediatric and young adult HSCT recipients
    Prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT).

Primary Outcome Measure

Incidence of Lung Injury after HSCT [ Time Frame: 24 months after HSCT ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158
Sana Noori
[email protected]
415-353-1248
Gabriel Salinas Cisneros, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Sonya Belimezova
[email protected]
720-777-5987
Hesham Eissa, MD (PRINCIPAL_INVESTIGATOR)
Paul Houin, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute/Boston Children's HospitalBostonMassachusetts02215
Mona Li
[email protected]
617-632-5727
Leslie Lehmann, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Tamara Griffin, BSN
[email protected]
612-301-0164
Phil Lacher
[email protected]
612-626-2977
Samuel Goldfarb, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Sara Loveless, BSN, RN
[email protected]
513-803-7656
Stella Davies, MBBS, PhD, MRCP (PRINCIPAL_INVESTIGATOR)
Jason Woods, PhD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
David Flynn
[email protected]
718-619-6663
Lisa Young, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of Medicine/Texas Children'S HospitalHoustonTexas77030
Martha Arredondo
[email protected]
832-824-1201
Erin Doherty, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Sheri Ballard, MPH
[email protected]
206-667-4222
Scott Baker, MD, MS (PRINCIPAL_INVESTIGATOR)
Seattle Children'S HospitalSeattleWashington98105
Sheri Ballard, MPH
[email protected]
206-667-4222
Matthew Abts, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Francisco· San Francisco, CAChildren's Hospital Colorado· Aurora, CODana-Farber Cancer Institute/Boston Children's Hospital· Boston, MAUniversity of Minnesota· Minneapolis, MNCincinnati Children's Hospital Medical Center· Cincinnati, OHChildren's Hospital of Philadelphia· Philadelphia, PA

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