Studies & Statistics for Integrated Research and Projects
Therapy Optimisation Studies (TOS) to guarantee better chances of survival of children and adolescents with cancer.
The Clinical Trial Unit for Studies & Statistics for Integrated Research & Projects (S2IRP) is an important link between the CCRI laboratory research activities and the clinical application of trials at the St. Anna Children’s Hospital. Essentially, S2IRP fosters clinical research in paediatric oncology by coordinating and facilitating international clinical trials.
Within the CCRI, the S2IRP is the centre of excellence for clinical studies and statistics. The S2IRP acts as the study centre for prospective clinical trials aiming to optimise therapies according to EU directives and the Austrian Pharmaceuticals Act (AMG). In addition, by running specific projects various international cooperations are maintained. The skilled multidisciplinary team and personnel resources enable the preparation, coordination and quality-control of TOS. This allows verification of the results and implementation of innovative stratifying diagnostics to optimise risk-adapted treatments.
For more information about our Clinical Trial Unit please visit the S2IRP section.
European Reference Networks (ERNs) represent an ambitious initiative from the European Commission, which is funded under its 3rd Health Programme. ERNs are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. The ERN initiative is mainly driven by EU countries. The Board of Member States is the formal body in charge of the approval and termination of networks and memberships as provided in the Commission's Implementing Decision. The Board is comprised of representatives of the 28 EU countries and the EEA countries.
To review a patient’s diagnosis and treatment, ERN coordinators will convene a “virtual” advisory board of medical specialists across different disciplines, using a dedicated IT platform and telemedicine tools. This way it is the medical knowledge and expertise that travel rather than the patients, who have the comfort of staying in their supportive home environments.
The first 24 ERNs were launched in 2017, involving more than 900 highly-specialised healthcare units from over 300 hospitals in 26 Member States. Prof Ruth Ladenstein is the coordinator of the European Reference Network on Paediatric Cancer (ERN-PaedCan), which aims at reducing inequalities in childhood cancer survival by providing high-quality, accessible and cost-effective cross-border healthcare to children and adolescents with cancer, regardless of where they live.
Ladenstein R, Pötschger U, Pearson ADJ, Brock P, Luksch R, Castel V, Yaniv I, Papadakis V, Laureys G, Malis J, Balwierz W, Ruud E, Kogner P, Schroeder H, de Lacerda AF, Beck-Popovic M, Bician P, Garami M, Trahair T, Canete A, Ambros PF, Holmes K, Gaze M, Schreier G, Garaventa A, Vassal G, Michon J, Valteau-Couanet D; SIOP Europe Neuroblastoma Group (SIOPEN) (2017). Busulfan and melphalan versus carboplatin, etoposide, and melphalan as high-dose chemotherapy for high-risk neuroblastoma (HR-NBL1/SIOPEN): an international, randomised, multi-arm, open-label, phase 3 trial. Lancet Oncol.18(4):500-514.
Viprey V, Gregory WM, Corrias MV, Tchirkov A, Swerts K, Vicha A, Dallorso S, Brock P, Luksch R, Valteau-Couanet D, Papadakis V, Laureys G, Schreier G, Pearson AD, Ladenstein R, Burchill S (2014) Neuroblastoma mRNAs predict outcome in children with stage 4 neuroblastoma: a European HR-NBL1/SIOPEN study. J Clin Oncol. 2014 Apr 1;32(10):1074-83.
Ladenstein R, Weixler S, Garaventa A, Baykan B, Bleeke M, Kunert R, Katinger D, Pribill I, Glander P, Bauer S , Pistoia V, Michon J, Lode HN (2013) Ch14.18 Antibody Produced in CHO Cells in Relapsed or Refractory Stage 4 Neuroblastoma Patients: A SIOPEN Phase 1 Study. Landesbioscience mAbs. 5(5):801-9
Ladenstein R, Pötschger U, Siabalis D, Garaventa A, Bergeron C, Lewis IJ, Stein J, Kohler J, Shaw PJ, Holter W, Pistoia V, Michon J. (2011) A dose finding study for the effective use of subcutaneous rIL-2 in an outpatient setting for stage 4 neuroblastoma after megatherapy and autologous stem cell reinfusion. J Clin Oncol. 29(4):441-8.
Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Pötschger U, Pearson A. (2010) Randomized Trial of Prophylactic Granulocyte Colony-Stimulating Factor During Rapid COJEC Induction in Pediatric Patients With High-Risk Neuroblastoma: The European HR-NBL1/SIOPEN Study. J Clin Oncol. 28(21):3516-24
Ladenstein R, Pötschger U, Le Deley MC, Whelan J, Paulussen M, Oberlin O, van den Berg H, Dirksen U, Hjorth L, Michon J, Lewis I, Craft A and Jürgens H. (2010 ) Primary Disseminated Multifocal Ewing Sarcoma: Results of the Euro-EWING 99 Trial. J Clin Oncol. 201:28(21):3284-91.