Active Research

  • (RTTI_Tiratricol-EAP-MCT8- 2022-4) Expanded Access Program for Tiratricol in Patients with Monocarboxylate Transporter 8 Deficiency also known as Allan-Herndon-Dudley syndrome (AHDS)

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: 2023-070 (OPEN)

  • 10-CBA, A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications

    Primary Investigator: Eames MD, Gretchen

    IRB ID: 2023-095 (OPEN)

  • 111-902, A Multicenter Multinational Observational Study of Children with Hypochondroplasia

    Primary Investigator: Steelman MD, Joel

    IRB ID: 2024-023 (OPEN)

  • A COLLABORATIVE PHASE 2 STUDY OF VENETOCLAX IN COMBINATION WITH CONVENTIONAL CHEMOTHERAPY IN PEDIATRIC PATIENTS WITH ACUTE MYELOID LEUKEMIA

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2024-032 (OPEN)

  • A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

    Primary Investigator: Albritton MD, Karen

    IRB ID: 2023-034 (OPEN)

  • A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's disease

    Primary Investigator: Huang, MD, Clifton

    IRB ID: 2021-008 (OPEN)

  • A Multimodal Biomarker-based Predictive Model for Infantile Spasms

    Primary Investigator: Keator MD, Cynthia

    IRB ID: 2022-006 (OPEN)

  • A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2022-024 (OPEN)

  • A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG) ACNS1821

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2022-054 (OPEN)

  • A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged &ge; 1 to < 31 Years Old with First Relapse

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2021-006 (OPEN)

  • A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# 153036) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA

    Primary Investigator: Granger MD, Meaghan

    IRB ID: 2021-086 (TEMPORARILY CLOSED TO ACCRUAL)

  • A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2021-071 (OPEN)

  • A PHASE 2, TWO-STAGE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF RLS-0071 IN NEWBORNS WITH MODERATE OR SEVERE HYPOXIC-ISCHEMIC ENCEPHALOPATHY UNDERGOING THERAPEUTIC HYPOTHERMIA WITH LONG-TERM FOLLOW-UP (STAR)

    Primary Investigator: Riley MD, David

    IRB ID: Premier_RLS-0071-202 (ReAlta)_Riley (OPEN)

  • A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma

    Primary Investigator: Albritton MD, Karen

    IRB ID: 2022-122 (OPEN)

  • A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2020-072 (OPEN)

  • A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2020-022 (OPEN)

  • A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

    Primary Investigator: Granger MD, Meaghan

    IRB ID: 2018-048 (OPEN)

  • A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2021-017 (TEMPORARILY CLOSED TO ACCRUAL)

  • A Phase 3, Open-label Study Evaluating the Long term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

    Primary Investigator: Pancham MD, Krishna

    IRB ID: 2022-056 (OPEN)

  • A Phase 3, open-label, single-arm, repeated-dose study to evaluate the safety and tolerability, pharmacokinetics, and antiviral activity of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have receiveda hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)

    Primary Investigator: Howrey MD, Richard P.

    IRB ID: 2022-044 (OPEN)

  • A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

    Primary Investigator: Marks MD, Warren

    IRB ID: 2022-027 (OPEN)

  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults with Developmental and Epileptic Encephalopathies

    Primary Investigator: Keator MD, Cynthia

    IRB ID: 2025-027 (OPEN)

  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults with Dravet Syndrome

    Primary Investigator: Perry MD, M. Scott

    IRB ID: 2025-024 (OPEN)

  • A phenomenological study of Cultural Humility in Patient and Physician Encounters

    Primary Investigator: Campbell, Throy

    IRB ID: 2023-081 (OPEN)

  • A Process Improvement Tool to Enhance and Monitor the Treatment of Children and Adolescents with Diabetic Ketoacidosis (DKA)

    Primary Investigator: Wilson MD, Don

    IRB ID: 2013-045 (OPEN)

  • A PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH A DIAGNOSIS OF SPINAL MUSCULAR ATROPHY (SMA) - (RESTORE)

    Primary Investigator: Acord, Stephanie

    IRB ID: 2019-052 (OPEN)

  • A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-C) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR RMS)

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2021-083 (TEMPORARILY CLOSED TO ACCRUAL)

  • A RETROSPECTIVE STUDY OF INOTUZUMAB OZOGAMICIN IN PATIENTS WITH DOWN SYNDROME AND ACUTELYMPHOBLASTIC LEUKEMIA

    Primary Investigator: Pacenta, Holly

    IRB ID: 2023-062 (OPEN)

  • A Safety and Feasibility Study to Evaluate Blood-Brain Barrier Disruption Using Exablate MR-Guided Focused Ultrasound in Combination with Doxorubicin in Treating Pediatric Patients with Diffuse Intrinsic Pontine Gliomas

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2024-119 (OPEN)

  • AALL1621, A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2017-049 (OPEN)

  • AALL2121: A Phase 2 study of revumenib (SNDX-5613) in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia

    Primary Investigator: Pacenta, Holly

    IRB ID: 2024-114 (TEMPORARILY CLOSED TO ACCRUAL)

  • ABX464-107: A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis.

    Primary Investigator: Huang, MD, Clifton

    IRB ID: 2022-103 (OPEN)

  • ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

    Primary Investigator: Albritton MD, Karen

    IRB ID: 2023-096 (OPEN)

  • ACP-101-303 (OLE): A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

    Primary Investigator: Roy, Sani

    IRB ID: 2023-068 (OPEN)

  • Activa Dystonia Therapy HDE

    Primary Investigator: Marks MD, Warren

    IRB ID: 593 (OPEN)

  • AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2017-030 (OPEN)

  • AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

    Primary Investigator: Albritton MD, Karen

    IRB ID: 2023-056 (OPEN)

  • ALTE05N1, Umbrella Long-Term Follow-up Protocol

    Primary Investigator: Beam MD, Donald

    IRB ID: 2010-109 (OPEN)

  • ALTE2131 Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer An NCORP Phase 3 Study

    Primary Investigator: Albritton MD, Karen

    IRB ID: 2025-025 (OPEN)

  • ALTE21C1: Assessment of Clonal Hematopoiesis and its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors

    Primary Investigator: Beam MD, Donald

    IRB ID: 2023-067 (OPEN)

  • An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

    Primary Investigator: Heym MD, Kenneth

    IRB ID: COG_AALL2131_Heym 2025-080 (OPEN)

  • An Open Label, Expanded Access Protocol Using 131I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients with Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma (not eligible for approved treatment)

    Primary Investigator: Granger MD, Meaghan

    IRB ID: 2012-026 (OPEN)

  • An Open-label, Multi-center, Phase IV, Rollover Study for Patients with Sickle Cell Disease who have Completed a prior Novartis-Sponsored Crizanlizumab Study

    Primary Investigator: Johnson MD, Clarissa

    IRB ID: 2021-060 (OPEN)

  • An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects 2 to < 5 Years of Age With Osteogenesis Imperfecta Types I, III or IV.

    Primary Investigator: Steelman MD, Joel

    IRB ID: 2023-024 (OPEN)

  • ANBL2131: A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

    Primary Investigator: Greer MD, Chelsee

    IRB ID: 2024-050 (OPEN)

  • APAL2020SC: Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2024-008 (OPEN)

  • APEC1621SC: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2017-065 (OPEN)

  • ARAR2221: A Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)

    Primary Investigator: Greer MD, Chelsee

    IRB ID: 2024-071 (OPEN)

  • ASH Data Hub: A Multi-Center Data Hub of Individuals Living with Hematologic Disease

    Primary Investigator: Johnson MD, Clarissa

    IRB ID: 2022-116 (OPEN)

  • BioMarin 111-210: A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature

    Primary Investigator: Steelman MD, Joel

    IRB ID: 2024-116 (OPEN)

  • BioMarin_111-903:A Multicenter, Observational Study to Characterize Growth in Children with Idiopathic Short Stature.

    Primary Investigator: Steelman MD, Joel

    IRB ID: 2024-115 (TEMPORARILY CLOSED TO ACCRUAL)

  • Blood Collection for National Marrow Donor Program

    Primary Investigator: Eames MD, Gretchen

    IRB ID: 2019-062 (OPEN)

  • BN44620: A PHASE IV OPEN-LABEL STUDY EVALUATING THE EFFECTIVENESS AND SAFETY OF RISDIPLAM ADMINISTERED AS AN EARLY INTERVENTION IN PEDIATRIC PATIENTS WITH SPINAL MUSCULAR ATROPHY AFTER GENE THERAPY

    Primary Investigator: Acord, Stephanie

    IRB ID: 2023-078 (OPEN)

  • Brain functional reorganization as a result of deep-brain stimulation therapy in children with dystonia

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2021-009 (OPEN)

  • CAMPFIRE: Children’s and Young Adult Master Protocol for Innovative Pediatric Research

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2020-066 (OPEN)

  • CHAT: A Multi-Institutional Children&rsquo;s Healthcare Advancements in Thrombosis Registry

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2022-077 (OPEN)

  • Clinical Assessment of Flow in Tetralogy of Fallot by Time-Resolved Volumetric Phase Contrast MRI.

    Primary Investigator: Muyskens MD, Steve

    IRB ID: 2015-047 (OPEN)

  • Clinical Characteristics and Outcomes of Community-Acquired Pneumonia (CAP) Requiring Hospitalization among Non-Lung Pediatric Solid Organ Transplant Recipients (pSOT).

    Primary Investigator: Rister, Nicholas

    IRB ID: 2025-138 (OPEN)

  • CliniMACS CD34+ T-cell Depletion of a Haploidentical Stem Cell Product as Part of a Treatment Protocol for Patients with Bone Marrow Failure

    Primary Investigator: Howrey MD, Richard P.

    IRB ID: 2018-041 (OPEN)

  • CNTO1959PBCRD3007, A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn&rsquo;s Disease (MACARONI-23) (Intervention Specific Appendix to Master Protocol PLATFORMPBCRD3001/I6T-MC-PIBD)

    Primary Investigator: Huang, MD, Clifton

    IRB ID: 2024-064 (OPEN)

  • COG_ALTE22C1 (DS-PALS Survivors)_Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

    Primary Investigator: Beam MD, Donald

    IRB ID: 2024-009 (OPEN)

  • Cognitive and Neuroimaging Biosignatures of Well-being in Youth with and without Seizures

    Primary Investigator: Cooper, Crystal

    IRB ID: 2020-104 (OPEN)

  • Combined Abnormal General Movement Assessment and High-Resolution Brain Magnetic Resonance Imaging as a Predictor of a Diagnosis of Cerebral Palsy among Patients withHypoxic-Ischemic Encephalopathy

    Primary Investigator: Johnson MD, Yvette

    IRB ID: CCMC_MRI and GMA_Johnson (OPEN)

  • Congenital Adrenal Hyperplasia Registry for Research and Quality Data Collection

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: CCHCS_CAH Registry_Thornton (OPEN)

  • COntemporary Infant and Neonatal Dialysis Study (COINED)

    Primary Investigator: Razzouk MD, Randa

    IRB ID: 2023-047 (OPEN)

  • Cook Children’s Health Care System Stroke and Thrombosis Registry

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2020-037 (OPEN)

  • Correlation of non-invasive diastolic parameters with invasive filling pressures in single ventricle patients

    Primary Investigator: Loar, Robert

    IRB ID: 2020-103 (OPEN)

  • Cortisol Production in Children and Adolescents with Prader-Willi Syndrome

    Primary Investigator: Roy, Sani

    IRB ID: 2024-002 (OPEN)

  • CYP-001: Copper Histidinate Treatment for Menkes Disease

    Primary Investigator: Stigall, William

    IRB ID: 2024-088 (OPEN)

  • Does treatment with Diazoxide elevate the plasma glucose levels in persons with GLUT1 Deficiency Syndrome? An open label, multiple ascending dose study

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: CCMC_Glut1DS Diazoxide_Thornton (OPEN)

  • DSM-PROT-005200: A Multi-Site Clinical Evaluation of the Simplexa COVID-19/Flu A/B & RSV Direct Assay in Symptomatic Patients

    Primary Investigator: Pence, Morgan

    IRB ID: 2024-102 (OPEN)

  • Electrophysiological Biomarkers of GABA Metabolism in Children with Genetic Epilepsy Syndromes

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2022-051 (OPEN)

  • Electrophysiological Biomarkers of GABA metabolism in children with SCN1A+ Dravet Syndrome

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2022-055 (OPEN)

  • EMAtS registry

    Primary Investigator: Tran, Lihn

    IRB ID: 2024-111 (OPEN)

  • ENDEAVOR: A CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETX101, AN AAV9 DELIVERED GENE THERAPY IN INFANTS AND CHILDREN WITH SCN1A POSITIVE DRAVET SYNDROME

    Primary Investigator: Perry MD, M. Scott

    IRB ID: 2022-076 (OPEN)

  • Evaluation of the outcome of surgical intervention on the upper extremity in young patients with hemipelgia

    Primary Investigator: Marshall MD, James

    IRB ID: 2020-098 (OPEN)

  • Exploration of Perceived Stress, Sleep, Fatigue, Physical Activity, and Biomarkers in Childhood Brain Tumor Survivors

    Primary Investigator: Bashore NP, Lisa M

    IRB ID: 2018-010 (OPEN)

  • Focal Cerebral Arteriopathy Steroid (FOCAS) Trial (Comparative Effectiveness Trial)

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2023-029 (OPEN)

  • Fort Worth AYA Oncology Coalition Registry Database

    Primary Investigator: Albritton MD, Karen

    IRB ID: 2019-017 (OPEN)

  • Functional Characterization of Children with Chronic Venous Thromboembolic Disease

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2021-065 (OPEN)

  • Gastroschisis Outcomes of Delivery Bank

    Primary Investigator: Riley MD, David

    IRB ID: 2024-066 (OPEN)

  • Genzyme Rare Disease Registries

    Primary Investigator: Gillespie MD, Robert

    IRB ID: 2009-043 (OPEN)

  • GOOD Study: Gastroschisis Outcomes of Delivery Study

    Primary Investigator: Riley MD, David

    IRB ID: 2023-004 (OPEN)

  • H-40889 Clinical Predictors of Treatment-Related Toxicity Among Children Receiving Cancer Therapy

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2019-051 (OPEN)

  • Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy

    Primary Investigator: Beam MD, Donald

    IRB ID: 2014-023 (OPEN)

  • HPC-Cord Blood 6637-01, A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

    Primary Investigator: Eames MD, Gretchen

    IRB ID: 2015-077 (OPEN)

  • Hyperinsulinism Center Registry for Research and Quality Data Collection

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: 2011-183 (OPEN)

  • I6T-MC-AMAY, A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease (ISA Title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab inPediatric Crohn’s Disease)

    Primary Investigator: Huang, MD, Clifton

    IRB ID: 2024-065 (OPEN)

  • Ictal and Interictal High-Frequency Electrophysiological Activity for the Localization of the Epileptogenic Zone in Children with Refractory Epilepsy

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2019-070 (OPEN)

  • Identification of and Genomic Editing of Novel Gene Mutations in Congenital Hyperinsulinism

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: 2023-059 (OPEN)

  • Improving Diagnosis and Treatment in CPVT

    Primary Investigator: Barker, Gregory

    IRB ID: 2022-002 (OPEN)

  • International Paediatric Stroke Study-Towards the Establishment of Standards of Practice and the Initiation of Multi-Center, Multi-National Clinical Trials for Neonates and Children with Stroke (IPSS)

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2012-008 (OPEN)

  • IPIG 5674-0001 Observational Registry Protocol: The International PNH Interest Group PNH Registry

    Primary Investigator: Beam MD, Donald

    IRB ID: 2022-093 (OPEN)

  • Kaposiform Hemangioendothelioma: Hematology and Oncology Survey Study (KHHAOS Study)

    Primary Investigator: Heym MD, Kenneth

    IRB ID: 2021-051 (OPEN)

  • KiteLock&trade; RCT: SAFETY AND EFFECTIVENESS OF 4% TETRASODIUM ETHYLENEDIAMINETETRAACETIC ACID CATHETER LOCK SOLUTION IN PREVENTING CENTRAL VENOUS CATHETER OCCLUSIONS IN CHILDREN WITH INTESTINAL FAILURE: A RANDOMIZED CONTROLLED TRIAL

    Primary Investigator: Osuntokun MD, Bankole Oluseyi

    IRB ID: 2024-035 (OPEN)

  • Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

    Primary Investigator: Pacenta, Holly

    IRB ID: 2020-101 (OPEN)

  • MULTI-CENTER MOLECULAR DIAGNOSIS AND HOST RESPONSE OF RESPIRATORY VIRAL INFECTIONS IN PEDIATRIC TRANSPLANT RECIPIENTS (VIPER)

    Primary Investigator: Whitworth MD, M. Suzanne

    IRB ID: 2022-080 (OPEN)

  • Multi-modal neuroimaging in children with cerebral palsy to assess functional and anatomical reorganization in relation to sensory and motor functions

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2019-068 (OPEN)

  • n/a

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2025-046 (OPEN)

  • NANT 2021-01: PHASE II STUDY OF EX-VIVO EXPANDED ALLOGENEIC UNIVERSAL DONOR TGF&beta;i NK CELL INFUSIONS IN COMBINATION WITH TEMOZOLOMIDE, IRINOTECAN, DINUTUXIMAB, AND SARGRAMOSTIM IN PATIENTS WITH RELAPSED OR REFRACTORY NEUROBLASTOMA The STING (Sequential Temozolomide, Irinotecan, NK cells and GD2 mAb) Trial

    Primary Investigator: Greer MD, Chelsee

    IRB ID: 2024-080 (OPEN)

  • National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease

    Primary Investigator: Roten, Lisa

    IRB ID: 2017-032 (OPEN)

  • National Registry of Pediatric Cancer Patients Diagnosed with COVID-19

    Primary Investigator:

    IRB ID: 2020-034 (OPEN)

  • Nationwide_Epilepsy Multi-Site: Comprehensive Profiling of Neurological Disorders of Somatic Etiology Accelerator Protocol

    Primary Investigator: Perry MD, M. Scott

    IRB ID: 2024-046 (OPEN)

  • n-Lorem_An open-label, single center, single participant study of an experimental antisense oligonucleotide treatment for TUBB4A-related leukodystrophy

    Primary Investigator: Acosta MD, Fernando

    IRB ID: 2024-122 (OPEN)

  • NN7415-4616: Open-label study investigating efficacy, safety and pharmacokinetics of concizumab prophylaxis in children below 12 years with haemophilia A or B with or without inhibitors

    Primary Investigator: McCavit MD, Timothy

    IRB ID: 2024-012 (OPEN)

  • Observational study of pediatric thrombotic disease: the Throm-PED registry

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2021-085 (OPEN)

  • Participation in the Cystic Fibrosis Patient Registry

    Primary Investigator: Schultz MD, Karen D

    IRB ID: 394 (OPEN)

  • Pediatric International DBS Registry (PEDiDBS)

    Primary Investigator: Marks MD, Warren

    IRB ID: 2016-013 (OPEN)

  • Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children with Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry

    Primary Investigator: Gillespie MD, Robert

    IRB ID: 2025-038, 2025-039 (OPEN)

  • PERC_Epilepsy Genetics Database

    Primary Investigator: Keator MD, Cynthia

    IRB ID: 2023-074 (TEMPORARILY CLOSED TO ACCRUAL)

  • Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2018-089 (OPEN)

  • PLATFORMPBCRD3001/I6T-MC-PIBD, A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease

    Primary Investigator: Huang, MD, Clifton

    IRB ID: 2024-063 (OPEN)

  • Prader-Willi Syndrome Registry

    Primary Investigator: Roy, Sani

    IRB ID: CCHCS_PWS-Registry_Roy (OPEN)

  • Prader-Willi Syndrome-Clinical Investigation Collaborative (PWS-CLIC) STUDYTRAX Clinical Database

    Primary Investigator: Roy, Sani

    IRB ID: FPWR_PWS StudyTrax_Roy (OPEN)

  • Presurgical Mapping of the Eloquent Cortex in Children with Drug Resistant Epilepsy Using Videogames

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2024-028 (OPEN)

  • Project DANCES (Diversity in Aya caNCEr Survivors)

    Primary Investigator:

    IRB ID: 2024-048 (OPEN)

  • Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma (ARST2032)

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2022-072 (OPEN)

  • PROTOCOL FOR A RESEARCH DATABASE FOR HEMATOPOIETIC CELL TRANSPLANTATION, OTHER CELLULAR THERAPIES AND MARROW TOXIC INJURIES

    Primary Investigator: Eames MD, Gretchen

    IRB ID: 2019-061 (OPEN)

  • PRWCC_Foresight, Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy

    Primary Investigator: Pacenta, Holly

    IRB ID: 2024-059 (OPEN)

  • Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2019-085 (OPEN)

  • RANDOMIZATION OF CYTARABINE MONOTHERAPY VERSUS STANDARD-OF-CARE VINBLASTINE/PREDNISONE FOR FRONTLINE TREATMENT OF LANGERHANS CELL HISTIOCYTOSIS (TXCH LCH0115)

    Primary Investigator: Ray MD, Anish

    IRB ID: 2019-067 (OPEN)

  • RBDD-PLG Project; International Retrospective and Prospective Study of Individuals affected with Hypoplasminogenemia

    Primary Investigator: Torres MD, Marcela

    IRB ID: 2019-028 (OPEN)

  • Retrospective data analysis of neurophysiological data for intraoperative or epilepsy monitoring. An international, retrospective, multi-site study.

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2022-059 (OPEN)

  • Robot-assisted hand training to induce manual functional change and cerebral neural plasticity in children with cerebral palsy

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2021-012 (OPEN)

  • Safety, Accuracy, and Feasibility of Continuous Glucose Monitoring In the Neonatal Intensive Care Unit

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: CCHCS_CGM_Thornton (OPEN)

  • Seizures and Children&apos;s Outcomes After Stroke (SCOUTS)

    Primary Investigator: Herring, Rachelle

    IRB ID: 2022-067 (OPEN)

  • Sensory and Affective Processing in Children with Autism Spectrum Disorder

    Primary Investigator: Papadelis, PhD, Christos

    IRB ID: 2024-047 (OPEN)

  • Signatera Efficacy Study

    Primary Investigator:

    IRB ID: Dell Childrens_Signatera Efficacy_Ray (OPEN)

  • SJiMB21, Phase 2 Study of Molecular and Clinical Risk-Directed Therapy for Infants and Young Children with Newly Diagnosed Medulloblastoma

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2023-057 (OPEN)

  • SRP-9001-401: A Long-term Multicenter Prospective Observational Study Evaluating the Comparative Effectiveness and Safety of Sarepta Gene Transfer Therapy vs. Standard of Care in Participants with Duchenne Muscular Dystrophy under Conditions of Routine Clinical Practice

    Primary Investigator: Marks MD, Warren

    IRB ID: 2023-084 (OPEN)

  • STK-001-DS-301_Stoke_Dravet Syndrome

    Primary Investigator: Perry MD, M. Scott

    IRB ID: Stoke_STK-001-DS-301_Perry (OPEN)

  • STOP360-IP-22: Standardizing Treatments for Pulmonary Exacerbations: A platform for evaluating treatment decisions to improve outcomes (STOP360)

    Primary Investigator: Schultz MD, Karen D

    IRB ID: 2022-091 (OPEN)

  • Survey of the National Lipid Association s Membership - Opinions of the 2011 National Heart, Lung and Blood Institute s Expert Panel Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents.

    Primary Investigator: Wilson MD, Don

    IRB ID: 2013-028 (OPEN)

  • Targeted approach to Langerhans Cell Histiocytosis (LCH) using MEK inhibitor, Trametinib.

    Primary Investigator: Ray MD, Anish

    IRB ID: 2023-058 (OPEN)

  • TDN_REACH-OB-23: A Research Study to Advance the CF Therapeutics Pipeline for People without Modulators

    Primary Investigator: Schultz MD, Karen D

    IRB ID: 2024-070 (OPEN)

  • Test protocol

    Primary Investigator:

    IRB ID: CCHCS_Test_PI (OPEN)

  • Testicular tissue cryopreservation for fertility preservation in patients facing infertility-causing diseases or treatment regimens

    Primary Investigator: Palmer, MD, Blake

    IRB ID: 2020-053 (OPEN)

  • The American Thrombosis and Hemostasis Network (ATHN) National Web Tracker

    Primary Investigator: Sanders MD, Joann

    IRB ID: 2011-160 (OPEN)

  • The Cardiac High Acuity Monitoring Program (CHAMP) Data Repository (CHAMP App Repository)

    Primary Investigator: Roten, Lisa

    IRB ID: 2017-033 (OPEN)

  • The Impact of Massage Therapy on Post-Surgical Pain, Anxiety, Quality of Life, and Opioid Analgesia Exposure on Children after Thoracic or Lumbar Surgery

    Primary Investigator:

    IRB ID: 2020-088 (OPEN)

  • The Use of Fluorine F 18 6-fluorodopamine Positron Emission Tomography Combined with Computed Tomography in Congenital Hyperinsulinism and Insulinoma

    Primary Investigator: Thornton MD, Paul Stephen

    IRB ID: 2012-060 (OPEN)

  • Tissue Banking- Collecting and Banking Human Tissue Samples for Future Use

    Primary Investigator: Zhao, MD, Sibo

    IRB ID: 2020-093 (OPEN)

  • to assess the efficacy and safety of DefenCath in pediatric population who are on hemodialysis for kidney failure.

    Primary Investigator: Gillespie MD, Robert

    IRB ID: 2025-036 (OPEN)

  • Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

    Primary Investigator: Vallance MD, Kelly

    IRB ID: 2020-097 (OPEN)

  • U.S. Cohort of Parechovirus Meningoencephalitis Among Neonates and Young Infants (STU-2022-0580)

    Primary Investigator: Whitworth MD, M. Suzanne

    IRB ID: 2023-007 (OPEN)

  • Unknown

    Primary Investigator: Roy, Sani

    IRB ID: 2025-040 _Aardvark_AVK-101-301_Roy (OPEN)

  • unknown

    Primary Investigator: Pancham MD, Krishna

    IRB ID: 2025-011 (OPEN)

  • Unknown

    Primary Investigator: Whitworth MD, M. Suzanne

    IRB ID: Childrens National_RWE Maribavir_Whitworth (OPEN)

  • Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) and serum Cystatin C levels in children after Cardiopulmonary Bypass (CPB)

    Primary Investigator: Marshall MD, James

    IRB ID: 2020-041 (OPEN)

  • Using data from a network of patients, families, clinicians, researchers and health care organizations to improve care and outcomes for children, adolescents and young adults with Inflammatory Bowel Disease

    Primary Investigator: Ogunmola MD, Nick

    IRB ID: 2021-066 (OPEN)

  • Utility of RESPONDR® TNF, a laboratory developed diagnostic test, in a real-world inflammatory bowel disease population

    Primary Investigator: Huang, MD, Clifton

    IRB ID: Prometheus Laboratories_RESPONDR 24IBD02_Huang (OPEN)

  • UTSW_PELICAN: Predicting ECMO NeuroLogICal Injuries using mAchiNe Learning (PELICAN)

    Primary Investigator: Nkwantibisa, Raymond

    IRB ID: 2023-075 (OPEN)

  • UX143-CL301: An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta

    Primary Investigator: Steelman MD, Joel

    IRB ID: 2023-061 (OPEN)

  • VOG, A Retrospective Evaluation of High-Flow Intracranial Arteriovenous Malformations in Neonates: Clinical Management and Outcomes in North America

    Primary Investigator: Riley MD, David

    IRB ID: 2024-052 (OPEN)

  • VX21-147-301: Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease

    Primary Investigator: Gillespie MD, Robert

    IRB ID: 2023-069 (OPEN)

  • X4P-001-110: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of mavorixafor in participants with congenital and acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections.

    Primary Investigator: Beam MD, Donald

    IRB ID: 2024-091 (OPEN)