1,721,010 research outputs found
ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain
No full textIntroduction: Cancer and blood disorders in children are rare. The progressive improvement in survival over the last decades largely relies on the development of international academic clinical trials that gather the sufcient number of patients globally to elaborate solid conclusions and drive changes in clinical practice. The participation of Spain into large international academic trials has traditionally lagged behind of other European countries, mainly due to the burden of administrative tasks to open new studies, lack of fnancial support and limited research infrastructure in our hospitals. Methods: The objective of ECLIM-SEHOP platform (Ensayos Clínicos Internacionales Multicéntricos-SEHOP) is to overcome these difculties and position Spain among the European countries leading the advances in cancer and blood disorders, facilitate the access of our patients to novel diagnostic and therapeutic approaches and, most importantly, continue to improve survival and reducing long-term sequelae. ECLIM-SEHOP provides to the Spanish clinical investigators with the necessary infrastructural support to open and implement academic clinical trials and registries. Results: In less than 3 years from its inception, the platform has provided support to 20 clinical trials and 8 observational studies, including 8 trials and 4 observational studies where the platform performs all trial-related tasks (integral support: trial setup, monitoring, etc.) with more than 150 patients recruited since 2017 to these studies. In this manuscript, we provide baseline metrics for academic clinical trial performance that permit future comparisons. Conclusions: ECLIM-SEHOP facilitates Spanish children and adolescents diagnosed with cancer and blood disorders to access state-of-the-art diagnostic and therapeutic strategies
ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.
No full text20.500.12530/87892ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation. The platform's database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted. ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months. ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past
ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer
No full textDesarrollo de fármacos; Ensayos clínicos; Hematología y oncología pediátricaDrug development; Clinical trials; Pediatric hematology and oncologyDesenvolupament de fàrmacs; Assaigs clínics; Hematologia i oncologia pediàtricaIntroduction
ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation.
Methods
The platform’s database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted.
Results
ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months.
Discussion
ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.ECLIM-SEHOP was supported by the grant “Cáncer infantil y cánceres poco frecuentes 2018” from Asociación Española Contra el Cáncer (AECC) (Grant CICPF18016FERN 2018). Support is also received from Federación Española de Padres de Niños con Cáncer, Asociación Pablo Ugarte, Fundación Inocente, ACAYE, Uno entre cien mil and Fundación MAR
Supervivencia del cáncer infantil (0-14 años) por comunidades autónomas, cohorte de incidencia/diagnóstico 2010-2017
No full textEl Registro Español de Tumores Infantiles (RETI-SEHOP), es un proyecto conjunto de la Universidad de Valencia y la Sociedad Española de Hematología y Oncología Pediátricas (SEHOP) con la colaboración del Ministerio de Sanidad.
El Ministerio de Sanidad solicitó al RETI-SEHOP un análisis de supervivencia del cáncer infantil (0-14 años) por comunidades autónomas (CCAA), que permite identificar desigualdades en España dependiendo del lugar de residencia de los pacientes que son atendidos en Unidades de Oncología y Hematología Pediátricas; y evaluar la evolución de la supervivencia en las CCAA.
Metodología: Se analizó la supervivencia a 5 años del diagnóstico del periodo de incidencia/diagnóstico 2010-2017 en total y dividido en las cohortes 2010-2014 y 2015-2017, por el método Kaplan-Meier. Se realizó un análisis ajustado por edad, sexo, tipo de tumor y año de diagnóstico con un Modelo de Cox. También se estimó la supervivencia de todos los tumores, solo malignos, para 2019-2021, con el método periodo. No se calcula supervivencia para menos de 15 casos.
Resultados: En total se analizaron 8.056 casos para la cohorte 2010-2017 y 2.733 casos para 2019-2021, solo tumores malignos con un seguimiento activo global ≥96%.
La evolución de la supervivencia por cohortes de diagnóstico, partiendo de la cohorte previa 2008-2010, muestra una mejora de la supervivencia en el conjunto de España y una disminución de las diferencias entre CCAA.
Conclusión: La supervivencia del cáncer infantil en España mejora y las desigualdades entre CCAA tienden a reducirse.Ministerio de Sanida
Estimación de la supervivencia del cáncer infantil (0-14 años) en España, de los casos incidentes en 2019-2021, con el método periodo
No full textEl Registro Español de Tumores Infantiles (RETI-SEHOP), es un proyecto conjunto de la Universidad de Valencia y la Sociedad Española de Hematología y Oncología Pediátricas (SEHOP) con la colaboración del Ministerio de Sanidad.
En 2018 el Comité Interterritorial acuerda una nueva ordenación de la asistencia sanitaria del cáncer pediátrico, implementada progresivamente por las CCAA, que consistía en la asistencia en RED y la derivación de los casos más complejos a los hospitales más expertos.
Objetivos: Con el propósito de evaluar si dicha ordenación ha tenido un impacto en los resultados asistenciales, el Ministerio encarga al RETI-SEHOP estimar la supervivencia del cáncer infantil (0-14 años) en España a 5 años del diagnóstico, para los casos incidentes en 2019-2021. Estos resultados también se comparan con las supervivencias observadas para las cohortes de incidencia 2010-2013 y 2014-2017.
Método: Para el cálculo de la supervivencia a 5 años de la cohorte 2019-2021 se ha utilizado el método periodo.
Resultados: Casos incidentes en 2019-2021: 3.021; en 2010-2013: 3.973 y en 2014-2017: 4.083. Seguimiento activo ≥96% en las tres cohortes. Supervivencia global para las cohortes 2019-2021: 83,9% (82,6-85,3); 2010-2013: 80,9% (79,8-82,1) y 2014-2017: 83,3% (82,1-84,4). En el informe se detalla la supervivencia para los principales grupos tumorales.
Conclusiones: Los resultados de supervivencia para el periodo 2019-2021 siguen la tendencia de mejora experimentada en las últimas décadas y muestran una mejora moderada respecto de la cohorte anterior. Dado el comportamiento del método periodo, es esperable que los casos incidentes en 2019-2021 acaben teniendo una supervivencia observada ligeramente superior a la estimada cuando se complete su seguimiento a 5 años.
Los resultados de supervivencia, especialmente cuando se agregan distintos tipos de tumor, son el resultado de una interacción compleja de muchos factores que tienen que ver con el proceso diagnóstico, tratamientos, protocolos, etc. Entre estos factores se sitúa el plan de reordenación territorial que, aunque no ha provocado una mejora drástica inmediata (no esperable), debería tener un efecto positivo a largo plazo.Ministerio de Sanida
Going Beyond Counting First Authors in Author Co-citation Analysis
No full textThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Measurable Residual Disease Assessed by Flow-Cytometry Is a Stable Prognostic Factor for Pediatric T-Cell Acute Lymphoblastic Leukemia in Consecutive SEHOP Protocols Whereas the Impact of Oncogenetics Depends on Treatment
No full textAltres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER).Robust and applicable risk-stratifying genetic factors at diagnosis in pediatric T-cell acute lymphoblastic leukemia (T-ALL) are still lacking, and most protocols rely on measurable residual disease (MRD) assessment. In our study, we aimed to analyze the impact of NOTCH1, FBXW7, PTEN, and RAS mutations, the measurable residual disease (MRD) levels assessed by flow cytometry (FCM-MRD) and other reported risk factors in a Spanish cohort of pediatric T-ALL patients. We included 199 patients treated with SEHOP and PETHEMA consecutive protocols from 1998 to 2019. We observed a better outcome of patients included in the newest SEHOP-PETHEMA-2013 protocol compared to the previous SHOP-2005 cohort. FCM-MRD significantly predicted outcome in both protocols, but the impact at early and late time points differed between protocols. The impact of FCM-MRD at late time points was more evident in SEHOP-PETHEMA 2013, whereas in SHOP-2005 FCM-MRD was predictive of outcome at early time points. Genetics impact was different in SHOP-2005 and SEHOP-PETHEMA-2013 cohorts: NOTCH1 mutations impacted on overall survival only in the SEHOP-PETHEMA-2013 cohort, whereas homozygous deletions of CDKN2A/B had a significantly higher CIR in SHOP-2005 patients. We applied the clinical classification combining oncogenetics, WBC count and MRD levels at the end of induction as previously reported by the FRALLE group. Using this score, we identified different subgroups of patients with statistically different outcome in both Spanish cohorts. In SHOP-2005, the FRALLE classifier identified a subgroup of high-risk patients with poorer survival. In the newest protocol SEHOP-PETHEMA-2013, a very low-risk group of patients with excellent outcome and no relapses was detected, with borderline significance. Overall, FCM-MRD, WBC count and oncogenetics may refine the risk-stratification, helping to design tailored approaches for pediatric T-ALL patients
Variations on the Author
No full text“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
ECLIM-SEHOP, a new platform to set up and develop international academic clinical trials for childhood cancer and blood disorders in Spain
No full textIntroduction:
Cancer and blood disorders in children are rare. The progressive improvement in survival over the last decades largely relies on the development of international academic clinical trials that gather the sufficient number of patients globally to elaborate solid conclusions and drive changes in clinical practice. The participation of Spain into large international academic trials has traditionally lagged behind of other European countries, mainly due to the burden of administrative tasks to open new studies, lack of financial support and limited research infrastructure in our hospitals.
Methods:
The objective of ECLIM-SEHOP platform (Ensayos Clínicos Internacionales Multicéntricos-SEHOP) is to overcome these difficulties and position Spain among the European countries leading the advances in cancer and blood disorders, facilitate the access of our patients to novel diagnostic and therapeutic approaches and, most importantly, continue to improve survival and reducing long-term sequelae. ECLIM-SEHOP provides to the Spanish clinical investigators with the necessary infrastructural support to open and implement academic clinical trials and registries.
Results:
In less than 3 years from its inception, the platform has provided support to 20 clinical trials and 8 observational studies, including 8 trials and 4 observational studies where the platform performs all trial-related tasks (integral support: trial setup, monitoring, etc.) with more than 150 patients recruited since 2017 to these studies. In this manuscript, we provide baseline metrics for academic clinical trial performance that permit future comparisons.
Conclusions:
ECLIM-SEHOP facilitates Spanish children and adolescents diagnosed with cancer and blood disorders to access state-of-the-art diagnostic and therapeutic strategies
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