A POST-AUTHORISATION SAFETY STUDY PATIENT REGISTRY OF PATIENTS WITH HIGH-RISK NEUROBLASTOMA BEING TREATED WITH THE MONOCLONAL ANTIBODY DINUTUXIMAB BETA.

Datos básicos

Código:
EUS-DIN-2019-01
Protocolo:
EUS-DIN-2019-01
EUDRACT:
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2019
Año de finalización:
ESTUDIO OBSERVACIONAL

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Grupos

Financiadores - Promotores

EUSA PHARMA (UK) LTD

Resultados del Ensayo Clínico


A Confidence Habitats Methodology in MR Quantitative Diffusion for the Classification of Neuroblastic Tumors.

Cerda Alberich, Leonor; (...); Marti-Bonmati, Luis

Article. 10.3390/cancers12123858. 2020

  • Open Access.

A NATIONAL PEDIATRIC NEURO-ONCOLOGY TUMOR BOARD INITIATIVE IN SPAIN: RESULTS OF A WEB-BASED SURVEY TO EVALUATE PARTICIPANT EXPERIENCE UTILIZING THIS RESOURCE

Illade, Laura; (...); Lassaletta, Alvaro

Article. 2022


A practical solution to estimate the sample size required for clinical prediction models generated from observational research on data

Baeza-Delgado, Carlos; (...); Marti-Bonmati, Luis

Article. 10.1186/s41747-022-00276-y. 2022

  • Open Access.

A randomized, open-label, phase 2 study evaluating abemaciclib in combination with irinotecan and temozolomide in participants with relapsed or refractory Ewing sarcoma

Van Hal, Gertjan; (...); Lewin, Jeremy Howard

Meeting Abstract. 2023


Adolescent cancer care: What has changed in Spain in the past decade?

Garrido Colino, Carmen; (...); Vagace Valero, Jose Manuel

Article. 10.1016/j.anpede.2023.01.003. 2023


Adolescent cancer care: What has changed in Spain in the past decade?

Garrido Colino, Carmen; (...); SEHOP

Article. 10.1016/j.anpedi.2022.09.012. 2023

  • Open Access.

Alectinib in pediatric patients with solid or CNS tumors harboring ALK-fusions: Emerging pharmacokinetic data from the iMATRIX alectinib phase I/II open-label, multi-center study

Doz, Francois; (...); Gajjar, Amar J.

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.3098. 2024

  • Open Access.

ASSESSMENT OF A NOVEL READY-TO-USE TEMOZOLOMIDE ORAL SUSPENSION IN CHILDREN WITH SOLID TUMORS: RESULTS OF TEMOKIDS, A POPULATION PHARMACOKINETIC, ACCEPTABILITY AND SAFETY PHASE-1 STUDY

Abbou, Samuel; (...); Metayer, Lucy

Meeting Abstract. 2023


Barriers and facilitators to the implementation of a new European eHealth solution (SurPass v2.0): the PanCareSurPass Open Space study.

de Beijer IAE; (...); Pluijm SMF

Article. 10.1007/s11764-023-01498-8. 2023

  • Open Access.

Cadmium (Cd) and Lead (Pb) topsoil levels and incidence of childhood leukemias

Asenjo S; (...); Ramis R

Article. 10.1007/s10653-021-01030-w. 2021


Cáncer en los primeros 18 meses de vida.

Urtasun Erburu A, Herrero Cervera MJ, Cañete Nieto A

Article. 10.1016/j.anpedi.2020.02.015. 2020

  • Open Access.

Cancer is not a risk factor for severe COVID-19 in children, except in patients with recent allogeneic hematopoietic stem cell transplantation or comorbidities.

Velasco Puyó P; (...); Astigarraga I

Article. 10.1002/pbc.31120. 2024


Casuística de tumor miofibroblástico inflamatorio en centro terciario.

Martínez Navarro G; (...); Fernández Navarro JM

Case Reports. 10.1016/j.anpedi.2020.12.007. 2021

  • Open Access.

Casuistics of inflammatory myofibroblastic tumor in a tertiary center.

Martínez Navarro G; (...); Fernández Navarro JM

Case Reports. 10.1016/j.anpede.2020.12.016. 2021

  • Open Access.

Central nervous system relapse in high-risk stage 4 neuroblastoma: The HR-NBL1/SIOPEN trial experience

Berlanga, P; (...); Ladenstein, R

Article. 10.1016/j.ejca.2020.10.020. 2021

  • Open Access.

Clinical Features of Neuroblastoma With 11q Deletion: An Increase in Relapse Probabilities In Localized And 4S Stages.

J Ribelles A; (...); Castel V

Article. 10.1038/s41598-019-50327-5. 2019

  • Open Access.

Cmo tratamos el hemangioendotelioma kaposiforme?

Huerta-Calpe S; (...); Pérez-Tarazona S

Article. 10.1016/j.anpedi.2018.09.002. 2019

  • Open Access.

Comparative Multicentric Evaluation of Inter-Observer Variability in Manual and Automatic Segmentation of Neuroblastic Tumors in Magnetic Resonance Images

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.3390/cancers14153648. 2022

  • Open Access.

Current status of precision medicine in pediatric oncology in Spain: a consensus report by the Spanish Society of Paediatric Haematology and Oncology (SEHOP).

Gargallo, P.; (...); Moreno, L.

Article. 10.1007/s12094-021-02759-7. 2022

  • Open Access.

Challenges in early phase clinical trials for childhood cancer during the COVID-19 pandemic: a report from the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP).

Rubio-San-Simon, A.; (...); Bautista, F.

Article. 10.1007/s12094-020-02399-3. 2021

  • Open Access.

Childhood and Adolescent Central Nervous System Tumours in Spain: Incidence and Survival over 20 Years: A Historical Baseline for Current Assessment.

Chirlaque MD; (...); The Spanish Childhood Cancer Epidemiology Working Group

Article. 10.3390/cancers15245889. 2023

  • Open Access.

Delving into the clinical impact of NETs in pediatric cancer.

Benavent N; (...); Medina P

Article. 10.1038/s41390-024-03437-4. 2024


Development of the ECLIM-SEHOP Clinical Trial Platform: Implementing International Academic Clinical Trials for Childhood Cancer and Blood Disorders in Spain

Fernandez-Teijeiro, A; (...); Moreno, L

Meeting Abstract. 2020


Distribution of segmental chromosomal alterations in neuroblastoma.

Juan Ribelles A; (...); Castel V

Article. 10.1007/s12094-020-02497-2. 2020


ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain.

Bautista, F; (...); Sociedad Española de Hematología y Oncología Pediátrica (SEHOP)

Article. 10.1007/s12094-019-02221-9. 2019

  • Open Access.

ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.

Juan-Ribelles A; (...); Fernández-Teijeiro A

Article. 10.1007/s12094-024-03445-0. 2024

  • Open Access.

Endocrinological late effects of oncologic treatment on survivors of medulloblastoma

Santos, ADH; (...); Nieto, AC

Article. 10.32641/rchped.v90i6.994. 2019


Evaluation of circulating tumor DNA by electropherogram analysis and methylome profiling in high-risk neuroblastomas

Trinidad, Eva Maria; (...); de Mora, Jaime Font

Article. 10.3389/fonc.2023.1037342. 2023

  • Open Access.

Exosomal microRNAs from Longitudinal Liquid Biopsies for the Prediction of Response to Induction Chemotherapy in High-Risk Neuroblastoma Patients: A Proof of Concept SIOPEN Study.

Morini M; (...); Varesio L

Article. 10.3390/cancers11101476. 2019

  • Open Access.

Germline Predisposition to Pediatric Cancer, from Next Generation Sequencing to Medical Care.

Gargallo P; (...); Cañete A

Article. 10.3390/cancers13215339. 2021

  • Open Access.

Germline variant in Ctcf links mental retardation to Wilms tumor predisposition

Gargallo, Pablo; (...); Font de Mora, Jaime

Article. 10.1038/s41431-022-01105-x. 2022


HIGH RISK NEUROBLASTOMA (HR-NB) WITH MNA AND AGE

Ladenstein, Ruth; (...); Canete, Adela

Meeting Abstract. 2023


High risk neuroblastoma (HR-NB) with MNA and age <18 months: Results from the HR-NBL1/SIOPEN trial

Ladenstein, Ruth Lydia; (...); Canete, Adela

Meeting Abstract. 2023


High-risk neuroblastoma: where do we go?

Cañete A

Editorial Material. 10.1016/j.annonc.2019.12.003. 2020

  • Open Access.

Imaging biomarkers and radiomics in pediatric oncology: a view from the PRIMAGE (PRedictive In silico Multiscale Analytics to support cancer personalized diaGnosis and prognosis, Empowered by imaging biomarkers) project.

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.1007/s00247-023-05770-y. 2023


Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe: A report from the Innovative Therapies for Children with Cancer (ITCC) consortium.

Rubio-San-Simón A; (...); Bautista F

Article. 10.1016/j.ejca.2020.09.024. 2020

  • Open Access.

Independent Validation of a Deep Learning nnU-Net Tool for Neuroblastoma Detection and Segmentation in MR Images

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.3390/cancers15051622. 2023

  • Open Access.

Initial report on Spanish pediatric oncologic, hematologic, and post stem cell transplantation patients during SARS-CoV-2 pandemic

Faura, A; (...); Dapena, JL

Letter. 10.1002/pbc.28557. 2020

  • Open Access.

International benchmarking of childhood cancer survival by tumour stage: First results of the BENCHISTA project

Pritchard-Jones, K.; (...); Gatta, G.

Meeting Abstract. 2024


International benchmarking of stage at diagnosis for six childhood solid tumours (the BENCHISTA project): a population-based, retrospective cohort study.

Botta, Laura; (...); Pritchard-Jones, Kathy

Article. 10.1016/S2352-4642(24)00302-X. 2025


Intratumoral immunosuppression profiles in 11q-deleted neuroblastomas provide new potential therapeutic targets.

Coronado, Esther; (...); Font de Mora, Jaime

Article. 10.1002/1878-0261.12868. 2021

  • Open Access.

IT-Related Barriers and Facilitators to the Implementation of a New European eHealth Solution, the Digital Survivorship Passport (SurPass Version 2.0): Semistructured Digital Survey.

de Beijer, Ismay A E; (...); Chronaki, Catherine

Article. 10.2196/49910. 2024

  • Open Access.

Lateral-type posterior fossa ependymomas in pediatric population

Miranda-Lloret, Pablo; (...); Llavador, Gemma

Article. 10.1016/j.neucir.2023.10.002. 2024

  • Open Access.

Lateral-type posterior fossa ependymomas in pediatric population.

Miranda-Lloret, Pablo; (...); Llavador, Gemma

Article. 10.1016/j.neucie.2023.10.001. 2024


Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050) : a multicentre, open-label, multicohort, phase 1/2 study

Gaspar, N; (...); Campbell-Hewson, Q

Article. 10.1016/S1470-2045(21)00387-9. 2021

  • Open Access.

Li-Fraumeni syndrome heterogeneity.

Gargallo P; (...); Cañete A

Review. 10.1007/s12094-019-02236-2. 2020


Liquidhope: methylome and genomic profiling from very limited quantities of plasma-derived DNA.

Trinidad EM; (...); Font de Mora J

Article. 10.1093/bib/bbac575. 2023

  • Open Access.

Long-Term Results for Infants with Neuroblastoma Treated Between 2000 and 2D004 According to INES Protocols -INESFU- A SIOPEN Study

Munzer, C; (...); Gambart, M

Meeting Abstract. 2019


Metabolomic profiling in neuroblastoma.

Quintás G; (...); Segura V

Article. 10.1002/pbc.28113. 2020


Methodological advances in the discovery of novel neuroblastoma therapeutics.

Segura MF; (...); Moreno L

Article. 10.1080/17460441.2022.2002297. 2022


Modeling Cardiotoxicity in Pediatric Oncology Patients Using Patient-Specific iPSC-Derived Cardiomyocytes Reveals Downregulation of Cardioprotective microRNAs.

Reinal, Ignacio; (...); Sepulveda, Pilar

Article. 10.3390/antiox12071378. 2023

  • Open Access.

MR Denoising Increases Radiomic Biomarker Precision and Reproducibility in Oncologic Imaging

Fernández Patón M; (...); Martí-Bonmatí L

Article. 10.1007/s10278-021-00512-8. 2021

  • Open Access.

MRI and Molecular Characterization of Pediatric High-Grade Midline Thalamic Gliomas: The HERBY Phase II Trial.

Rodriguez D; (...); Jaspan T

Article. 10.1148/radiol.211464. 2022

  • Open Access.

MTHFR and VDR Polymorphisms Improve the Prognostic Value of MYCN Status on Overall Survival in Neuroblastoma Patients

Olivera, GG; (...); Herrero, MJ

Article. 10.3390/ijms21082714. 2020

  • Open Access.

Neuroblastoma in Spain: Linking the national clinical database and epidemiological registries - A study by the Joint Action on Rare Cancers.

Cañete A; (...); Spanish Neuroblastoma Linkage Working Group (SpNbLinkWG)

Article. 10.1016/j.canep.2022.102145. 2022

  • Open Access.

Next-Generation Sequencing Identifies Potential Actionable Targets in Paediatric Sarcomas

Ribelles, AJ; (...); Canete, A

Article. 10.3390/jpm11040268. 2021

  • Open Access.

Optimising Urinary Catecholamine Diagnostics for Neuroblastoma Patients

Matser, Y; (...); Tytgat, G

Meeting Abstract. 2020


OUTCOME OF BRAF V600E PEDIATRIC GLIOMAS TREATED WITH TARGETED BRAF INHIBITION

Nobre, L; (...); Tabori, U

Meeting Abstract. 2020


Outcomes of BRAF V600E Pediatric Gliomas Treated With Targeted BRAF Inhibition.

Nobre L; (...); Tabori U

Article. 10.1200/PO.19.00298. 2020

  • Open Access.

Overall survival prediction and risk stratification in patients with neuroblastoma through machine learning in the large multi-institutional PRIMAGE cohort.

Lozano-Montoya, Jose; (...); Alberich-Bayarri, Angel

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.10054. 2024

  • Open Access.

Personalized Medicine in Infant Population with Cancer: Pharmacogenetic Pilot Study of Polymorphisms Related to Toxicity and Response to Chemotherapy.

Urtasun, Andrea; (...); Herrero, Maria Jose

Article. 10.3390/cancers15051424. 2023

  • Open Access.

Pharmacogenetics in Neuroblastoma: What Can Already Be Clinically Implemented and What Is Coming Next?

Olivera, GG; (...); Herrero, MJ

Review. 10.3390/ijms22189815. 2021

  • Open Access.

Phase 1 Combination Dose-Finding/Phase 2 Expansion Cohorts of Lenvatinib plus Etoposide plus Ifosfamide in Patients Aged 2 to <= 25 Years with Relapsed/Refractory Osteosarcoma

Gaspar, N; (...); Campbell-Hewson, Q

Meeting Abstract. 2019


Phase 1 Study of Regorafenib in Combination With Vincristine and Irinotecan in Pediatric Patients With Recurrent or Refractory Solid Tumors

Casanova, M; (...); Geoerger, B

Meeting Abstract. 2020


Phase I combination dose-finding/phase II expansion cohorts of lenvatinib plus etoposide plus ifosfamide in patients (pts) aged 2 to <= 25 years with relapsed/refractory (r/r) osteosarcoma

Gaspar, N; (...); Campbell-Hewson, Q

Meeting Abstract. 2019


Phase I study of regorafenib in combination with vincristine and irinotecan in pediatric patients with recurrent or refractory solid tumors.

Casanova, Michela; (...); Geoerger, Birgit

Meeting Abstract. 2020


Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050) ? .

Gaspar N; (...); Casanova M

Article. 10.1016/j.esmoop.2021.100250. 2021

  • Open Access.

Precision medicine in Ewing sarcoma: a translational point of view.

Gargallo P; (...); Cañete A

Review. 10.1007/s12094-020-02298-7. 2020


PRIMAGE project: predictive in silico multiscale analytics to support childhood cancer personalised evaluation empowered by imaging biomarkers.

Martí-Bonmatí L; (...); Neri E

Article. 10.1186/s41747-020-00150-9. 2020

  • Open Access.

Prognostic factors of early mortality in children and adolescents enrolled in oncology trials with a dose-finding part in the era of targeted and immune therapies: An Innovative Therapies for Children with Cancer (ITCC) study

Carceller, Fernando; (...); Moreno, Lucas

Meeting Abstract. 2023


Publisher Correction: Clinical Features of Neuroblastoma With 11q Deletion: An Increase in Relapse Probabilities In Localized And 4S Stages.

Juan Ribelles A; (...); Castel V

Correction. 10.1038/s41598-020-58428-2. 2020

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Radiological evaluation of newly diagnosed non-brainstem pediatric high-grade glioma in the HERBY phase II trial.

Rodriguez Gutierrez D; (...); Jaspan T

Article. 10.1158/1078-0432.CCR-19-3154. 2020

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Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials.

Kelly, Sarah M.; (...); Mandeville, Henry

Article. 10.1016/j.radonc.2023.109549. 2023

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Reasons for noncompliance with the national guidelines for initial antiretroviral therapy of HIV-infected patients in Spain, 2010-2015

Gonzalez, J; (...); Cohort Spanish HIV Res Network Co

Article. 10.1016/j.eimc.2019.02.007. 2019


Recommended phase 2 dose (RP2D) for abemaciclib in combination with irinotecan (IRN) and temozolomide (TMZ) in pediatric patients with relapsed/refractory solid tumors (JPCS Part A)

Lassaletta, Alvaro; (...); Juan-Ribelles, Antonio

Meeting Abstract. 2023


Regorafenib Plus Vincristine and Irinotecan in Pediatric Patients With Recurrent/Refractory Solid Tumors: An Innovative Therapies for Children With Cancer Study.

Casanova M; (...); Geoerger B

Article. 10.1158/1078-0432.CCR-23-0257. 2023

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RE-IRRADIATION FOR PROGRESSIVE DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG): THE SPANISH EXPERIENCE

Panizo, Elena; (...); Lassaletta, Alvaro

Meeting Abstract. 10.1093/neuonc/noae064.116. 2024

  • Open Access.

Reproducibility Analysis of Radiomic Features on T2-weighted MR Images after Processing and Segmentation Alterations in Neuroblastoma Tumors.

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.1148/ryai.230208. 2024

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Results of a survey on the treatment of adolescents and young adult (AYA) sarcoma patients in Spain at present time.

Mata Fernandez, Cristina; (...); Morales CV

Article. 10.1007/s12094-022-02912-w. 2022


Retinoblastoma and mosaic 13q deletion: a case report

Gargallo P; (...); Canete, A

Article. 10.1186/s40942-021-00321-9. 2021

  • Open Access.

Review: Ewing Sarcoma Predisposition.

Gargallo P; (...); Cañete A

Article. 10.1007/s12253-019-00765-3. 2019


Safety and PK (pharmacokinetic) profile of niraparib (nir) plus dostarlimab (dost) in pediatric patients (pts) with recurrent or refractory (RR) solid tumors: SCOOP study

Doz, Francois; (...); Rubio-San-Simon, Alba

Meeting Abstract. 2023


Staging childhood cancers in Europe: Application of the Toronto stage principles for neuroblastoma and Wilms tumour. The JARC pilot study.

Gatta G; (...); JARC Pilot Study Toronto Guidelines Working Group

Article. 10.1002/pbc.29020. 2021

  • Open Access.

Suprarenal Masses in Very Young Infants: Is It Safe to Watch and Wait? Report of a SIOPEN Observational Study Results

Papadakis, Vassilios; (...); Canete, Adela

Article. 10.3390/cancers14164007. 2022

  • Open Access.

Survival and Health Care Burden of Children With Retinoblastoma in Europe.

Virgili G; (...); Gatta G

Article. 10.1001/jamaophthalmol.2024.4140. 2024

  • Open Access.

THE BENCHISTA PROJECT: INTERNATIONAL BENCHMARKING OF CHILDHOOD CANCER SURVIVAL BY TUMOUR STAGE

Cortes, Angela Lopez; (...); Pritchard-Jones, Kathy

Article. 2022


The paediatric cancer clinical research landscape in Spain: a 13-year multicentre experience of the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

Rubio-San-Simon, A.; (...); Moreno, L.

Article. 10.1007/s12094-021-02649-y. 2021


Unraveling the extracellular matrix-tumor cell interactions to aid better targeted therapies for neuroblastoma

Burgos-Panadero, R; (...); Noguera, R

Article. 10.1016/j.ijpharm.2021.121058. 2021

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Vitronectin Levels in the Plasma of Neuroblastoma Patients and Culture Media of 3D Models: A Prognostic Circulating Biomarker?

Lopez-Carrasco, Amparo; (...); Noguera, Rosa

Article. 10.3390/ijms25168733. 2024

  • Open Access.

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