[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04098445":3,"trial-entities:NCT04098445":200,"trial-summary:NCT04098445":207},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":16,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":36,"minimum_age":16,"maximum_age":37,"healthy_volunteers":14,"eligibility_criteria":38,"std_ages":44,"locations":47,"central_contacts":187,"overall_officials":192,"references":194,"see_also_links":199},"NCT04098445","2019-0001C","TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients","RECRUITING","2033-09","2026-06","2026-06-22","2021-09-08","Children's Hospital Medical Center, Cincinnati","OTHER",false,"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.\n\nThis 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.",null,[18,19,20,21,22],"Hematopoietic Stem Cell Transplant (HSCT)","Diffuse Alveolar Hemorrhage","Thrombotic Microangiopathies","Interstitial Pneumonitis","Bronchiolitis Obliterans",[],"OBSERVATIONAL",[],{"count":27,"type":28},2000,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"Incidence of Lung Injury after HSCT","Participants will be assessed for lung injury at 24 months after HSCT","24 months after HSCT",[],"ALL","24 Years",{"inclusion":39,"exclusion":41,"raw_text":43},[40],"Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.",[42],"Subjects over 24 years of age.","Inclusion Criteria:\n\n* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.\n\nExclusion Criteria:\n\n* Subjects over 24 years of age.",[45,46],"CHILD","ADULT",[48,66,83,98,117,134,149,164,179],{"facility":49,"status":7,"city":50,"state":51,"zip":52,"country":53,"contacts":54,"geoPoint":63},"University of California San Francisco","San Francisco","California","94158","United States",[55,60],{"name":56,"role":57,"phone":58,"email":59},"Sana Noori","CONTACT","415-353-1248","sana.noori@ucsf.edu",{"name":61,"role":62},"Gabriel Salinas Cisneros, MD","PRINCIPAL_INVESTIGATOR",{"lat":64,"lon":65},37.77493,-122.41942,{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":53,"contacts":71,"geoPoint":80},"Children's Hospital Colorado","Aurora","Colorado","80045",[72,76,78],{"name":73,"role":57,"phone":74,"email":75},"Sonya Belimezova","720-777-5987","Sonya.Belimezova@childrenscolorado.org",{"name":77,"role":62},"Hesham Eissa, MD",{"name":79,"role":62},"Paul Houin, MD",{"lat":81,"lon":82},39.72943,-104.83192,{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":53,"contacts":88,"geoPoint":95},"Dana-Farber Cancer Institute\u002FBoston Children's Hospital","Boston","Massachusetts","02215",[89,93],{"name":90,"role":57,"phone":91,"email":92},"Mona Li","617-632-5727","Mona_Li@DFCI.HARVARD.EDU",{"name":94,"role":62},"Leslie Lehmann, MD",{"lat":96,"lon":97},42.35843,-71.05977,{"facility":99,"status":7,"city":100,"state":101,"zip":102,"country":53,"contacts":103,"geoPoint":114},"University of Minnesota","Minneapolis","Minnesota","55455",[104,108,112],{"name":105,"role":57,"phone":106,"email":107},"Tamara Griffin, BSN","612-301-0164","griffint@umn.edu",{"name":109,"role":57,"phone":110,"email":111},"Phil Lacher","612-626-2977","placher@umn.edu",{"name":113,"role":62},"Samuel Goldfarb, MD",{"lat":115,"lon":116},44.97997,-93.26384,{"facility":118,"status":7,"city":119,"state":120,"zip":121,"country":53,"contacts":122,"geoPoint":131},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[123,127,129],{"name":124,"role":57,"phone":125,"email":126},"Sara Loveless, BSN, RN","513-803-7656","Sara.Loveless@cchmc.org",{"name":128,"role":62},"Stella Davies, MBBS, PhD, MRCP",{"name":130,"role":62},"Jason Woods, PhD",{"lat":132,"lon":133},39.12711,-84.51439,{"facility":135,"status":7,"city":136,"state":137,"zip":138,"country":53,"contacts":139,"geoPoint":146},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[140,144],{"name":141,"role":57,"phone":142,"email":143},"David Flynn","718-619-6663","flynnd6@chop.edu",{"name":145,"role":62},"Lisa Young, MD",{"lat":147,"lon":148},39.95238,-75.16362,{"facility":150,"status":7,"city":151,"state":152,"zip":153,"country":53,"contacts":154,"geoPoint":161},"Baylor College of Medicine\u002FTexas Children'S Hospital","Houston","Texas","77030",[155,159],{"name":156,"role":57,"phone":157,"email":158},"Martha Arredondo","832-824-1201","Martha.Arredondo@bcm.edu",{"name":160,"role":62},"Erin Doherty, MD",{"lat":162,"lon":163},29.76328,-95.36327,{"facility":165,"status":7,"city":166,"state":167,"zip":168,"country":53,"contacts":169,"geoPoint":176},"Seattle Children'S Hospital","Seattle","Washington","98105",[170,174],{"name":171,"role":57,"phone":172,"email":173},"Sheri Ballard, MPH","206-667-4222","sballard@fredhutch.org",{"name":175,"role":62},"Matthew Abts, MD",{"lat":177,"lon":178},47.60621,-122.33207,{"facility":180,"status":7,"city":166,"state":167,"zip":181,"country":53,"contacts":182,"geoPoint":186},"Fred Hutchinson Cancer Center","98109",[183,184],{"name":171,"role":57,"phone":172,"email":173},{"name":185,"role":62},"Scott Baker, MD, MS",{"lat":177,"lon":178},[188],{"name":189,"role":57,"phone":190,"email":191},"Stephanie Edwards, BSN, RN","513-636-9292","StephanieL.Edwards@cchmc.org",[193],{"name":128,"affiliation":12,"role":62},[195],{"pmid":196,"type":197,"citation":198},"40692216","DERIVED","Koo J, Cooper R, Edwards SL, Lane A, Loveless SK, Strecker L, Lake KE, Myers KC, Towe C, Patti J, Walkup LL, Wikenheiser-Brokamp KA, MacMillan ML, Lacher P, Griffin T, Tekman M, Cisneros GS, Wu K, Zinter MS, Urrego FA, Baker KS, Abts MF, Ballard S, Freedman JL, Caraballo A, Young LR, Josephson MB, Allen JL, Camburn DM, Doherty EE, Azamian MS, Arredondo M, Silva-Carmona M, Lehmann LE, Wong W, Gaffin JM, McAlpine W, Li M, Goldfarb SB, Woods JC, Davies SM. High Prevalence of Abnormal Baseline Lung Function in Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients: A Report from the TRANSPIRE Study. Pediatr Blood Cancer. 2025 Oct;72(10):e31916. doi: 10.1002\u002Fpbc.31916. Epub 2025 Jul 21.",[],{"nct_id":4,"conditions":201,"biomarkers":206},[22,202,203,204,205],"Diffuse alveolar hemorrhage","Hematopoietic Cell Transplantation","Interstitial Pneumonia","Thrombotic Microangiopathy",[],{"nct_id":4,"found":208,"summary":209,"prompt_version":219},true,{"design":210,"status":211,"heading":212,"summary":213,"follow_up":214,"word_count":215,"commitments":216,"compensation":217,"drugs_mentioned":218},"This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 2000 participants.","completed","TRANSPIRE: Lung Injury in Pediatric HSCT Patients","This study is looking at lung problems that can happen in children and young adults after a hematopoietic stem cell transplant (HSCT). These problems can include diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA), interstitial pneumonitis (IPS), and bronchiolitis obliterans. The study aims to understand how often these lung injuries occur. We need to learn more about these complications to improve diagnosis and treatment. You may be able to join if you are 24 years old or younger and are having an allogeneic or autologous HSCT. The main goal is to see how many people develop lung injury within 24 months after their transplant. The study plans to enroll 2000 participants, but its current status is unclear.","The study will track the incidence of lung injury for 24 months after the HSCT.",116,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]