Clinical Trials and Research

Children’s Hospital participates in a number of clinical trials and research opportunities that benefit both the hospital and our patients.

All research is overseen by the Institutional Review Board.  The IRB reviews all research to make sure it is scientifically valid, conducted in such a way as to respect the rights and welfare of our patients, and maintains compliance with all applicable federal and institutional regulations and policies.  Composed of doctors, nurses, community members and hospital staff, the IRB brings together a wide variety of experience.  The IRB also serves to educate hospital staff on the different research processes at the hospital.

Children’s Hospital engages in a number of different types of research.  They include:

• Clinical Trials – Sponsored either by a private corporation or the National Institutes of Health, these trials provide practical investigation into a drug or medical device, to be used for future marketing applications.
• Registries – Children’s participates in a number of nationwide registries that capture data on specific populations for use in research of chronic pediatric conditions.  We contribute data to registries on hematology, cystic fibrosis, and diabetes.
• Oncology Research – The Craycroft Cancer Center at Children’s Hospital is part of the Children’s Oncology Group, participating in more than 100 ongoing clinical trials.
• Investigator Sponsored Research – The largest area of research at Children’s, these projects involve retrospective chart review.  Researchers look at data that has been collected to find trends in patient treatment and outcome, as well as answer questions that arise during research.

Current Clinical Trials

Oncology

• "A Phase III Trial of Treatment of Advanced Stage Ananplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) versus Consolidation with a Regimen Including Vinblastine"
  Physician investigator: Vonda Crouse, MD
• A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in Combination w/Standard Multiagent Chemotherapy for Patients w/Newly Diagnosed Ewing Sarcoma Family of Tumors
  Physician investigator: Vonda Crouse, MD
• National Wilms Tumor Late Effects Study
  Physician investigator: Vonda Crouse, MD
• Erwinia Asparaginase:  For Investigational Anti-tumor Therapy
  Physician investigator: Vonda Crouse, MD
• Northern California Childhood Leukemia (UCB) (nee:Molecular Epidemiology of Childhood Leukemia & Environmental Exposures)
  Physician investigator: Vonda Crouse, MD
• Perinatal Neuroblastoma: Expectant Observation
  Physician investigator: Vonda Crouse, MD
• Osteosarcoma biology protocol:  Companion to intergroup therapeutic studies
  Physician investigator: Vonda Crouse, MD
• A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease
  Physician investigator: Vonda Crouse, MD
• Phase III Randomized Study of Chimeric Anti-GD1 in High Risk Neuroblastoma Following Myeloablative therapy and Autologous Stem Cell Rescue
  Physician investigator: Vonda Crouse, MD
• A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumor
  Physician investigator: Vonda Crouse, MD
• Classification of Acute Lymphoblastic Leukemia
  Physician investigator: Vonda Crouse, MD
• High Risk B-Precursor Acute Lymphoblastic Leukemia
  Physician investigator: Vonda Crouse, MD
• A Phase III Study of Reduced Therapy in the Treatment of Children w/Low & Intermediate Risk Germ Cell Tumors
  Physician investigator: Vonda Crouse, MD
• A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
  Physician investigator: Vonda Crouse, MD
• A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated with LMB/FAB Ther
  Physician investigator: Vonda Crouse, MD
• A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery to Eliminate All Measurable Disease Prior to Radiotherapy for Non-Germinomatous Germ Cell Tumors (NGGCT)
  Physician investigator: Vonda Crouse, MD
• A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma:  A Phase III Double Randomized Trial
  Physician investigator: Vonda Crouse, MD
• "Vincristine, Dactinomycin & Lower Doses of Cyclophosphamide with/without Radiation Therapy for Patients w/Newly Diagnosed Low-Risk Embryonal/Botryoid Rhabdomyosarcoma"
  Physician investigator: Vonda Crouse, MD
• Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL)
  Physician investigator: Vonda Crouse, MD
• Low Birth Weight and Other Risk Factors for Hepatoblastoma
  Physician investigator: Vonda Crouse, MD

Hematology

• Thalassemia Clinical Research Network Registry
  Physician investigator: Robert Mignacca, MD 
• Data collection on complications of Hemophilia and serum testing and storage
  Physician investigator: Robert Mignacca, MD
• The Severe Chronic Neutropenia International Registry (SCNIR)
  Physician investigator: Robert Mignacca, MD
• Epidemiology and Treatment of Circulating Anticoagulants in Patients w/Hemophilia & vonWillebrand's Disease-The HTRS Registry
  Physician investigator: Robert Mignacca, MD
• Molecular Diagnosis of Bleeding Risk Factors in Von Willebrand Disease (VWD) Type I
  Physician investigator: Robert Mignacca, MD

Cardiac Surgery

• Closure of Atrial Septal Defects w/ the Amplatzer Septal Occluder Post-Market Study (ASD PMS II)
  Physician investigator: Carl Owada, MD

Cardiology

• Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) with the Spiral Coils
  Physician investigator: Carl Owada, MD
• Use of the Contegra Pulmonary Valve Conduit in Appropriate Patients at Children's Hospital Central California
  Physician investigator:  Edwin Petrossian, MD
• Outcomes after the Extracardiac Conduit Fontan Operation
  Physician investigator: Edwin Petrossian, MD
• Protocol for Use of 15mm St. Jude Medical Mechanical Aorta or Mitral Prosthetic Heart Valve
  Physician investigator: Edwin Petrossian, MD
• Closure of Muscular Ventricular Septal Defects with the AMPLATZER (Muscular VSD Occluder) Post Approval Study (Muscular VPA Study)
  Physician investigator: Carl Owada, MD

Pulmonology

• Cystic Fibrosis Patient Registry
  Physician investigator: Reddivalam Sudhakar, MD

Plastic Surgery

• The Role of Cux1 in Mammalian Limb Development
  Physician investigator: Peter Witt, MD

Endocrinology

• "The Norditropin National Registry, Version 2:  June 7, 2002, MIRA Version 06/12/02, Revised 02/10/03"
  Physician investigator: Swati Banerjee, MD
• "Genentech National Cooperative Study Post Marketing Surveillance Program and Nutropin Depot (For Injectable Suspension), Nutropin AQ (Injection), Nutropin, and Protropin"
  Physician investigator: Swati Banerjee, MD Endocrinology Metabolism
• TrialNet Natural History Study of the Development of Type I Diabetes
  Physician investigator: Swati Banerjee, MD
• GeNeSIS - The Genetics and Neuroendocrinology of Short Stature International Study
  Physician investigator: Jil Huong Nguyen, MD

Orthopedics

• "The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study (BrAIST) - Scoliosis: A Prospective, Randomized Controlled Study (BrAIST)"
  Physician investigator: Joseph Gerardi, DO 
• Verticle Expandable Prosthetic Titanium Rib (VEPTR)
  Physician investigator: Michael Elliot, MD
• The Chest Wall and Spine Deformity Registry
  Physician investigator: Michael Elliott, MD
• Humeral Osteotomy for the Correction of Traumatic Childhood Cubitus Varus
  Physician investigator: William Hennrikus, MD

Pediatric Intensive Care Unit

• Clinical Process Control Improvement w/Bedside Computerized Insulin Therapy for Blood Glucose in Adult and Pediatric ICU Patients; Ph 2 - Distribution and Implementation of Validated eProtocol-Insulin in Naïve ICUs
  Physician investigator: Ana Graciano, MD

Infectious Disease

• Rilonacept for Treatment of Familial Mediterranean Fever (FMF)
  Physician investigator: Dowain Wright, MD, PhD

Education

• Evaluation of Printed Health Education Materials at Children's Hospital Central California
  Investigator: Ashley Ave

Pharmacy

• Outcomes of a Clinical Pharmacist Managed Outpatient Pediatric Oral Anticoagulation Service: Comparison w/Management by a Pediatric Cardiology Service
  Investigator: Alavioon