© The Korean Urological Association, 2020.A disease-specific biomarker (or biomarkers) is a characteristic reflecting a pathological condition in human body, which can be used as a diagnostic or prognostic tool for the clinical management. A urine-based biomarker(s) may provide a clinical value as attractive tools for clinicians to utilize in the clinical setting in particular to bladder diseases including bladder cancer and other bladder benign dysfunctions. Urine can be easily obtained by patients with no preparation or painful procedures required from patients' side. Currently advanced omics technologies and computational power identified potential omics-based novel biomarkers. An unbiased profiling based on transcriptomics, proteomics, epigenetics, metabolomics approaches et al. found that expression at RNA, protein, and metabolite levels are linked with specific bladder diseases and outcomes. In this review, we will discuss about the urine-based biomarkers reported by many investigators including us and how these biomarkers can be applied as a diagnostic and prognostic tool in clinical trials and patient care to promote bladder health. Furthermore, we will discuss how these promising biomarkers can be developed into a smart medical device and what we should be cautious about toward being used in real clinical setting. © The Korean Urological Association, 2020.Metastatic prostate cancer is a heterogeneous disease entity. Men without prior androgen deprivation therapy exposure are termed metastatic castration sensitive prostate cancer (mCSPC). The goal of this article is to update the reader on the rapidly changing landscape of treatment for men with mCSPC. Along with the options available to the clinician for treatment of men with mCSPC, the care of these patients has evolved into a multi-disciplinary field with expanding roles for medical, urologic, and radiation oncologists. © The Korean Urological Association, 2020.Stamping processing is commonly used to form medical devices and implant. However, for biodegradable Mg alloy, the stamping will influence the degradation behavior because of the change in microstructure after stamping. So in this study, the As-rolled Mg-2Zn-0.5Nd alloy (ZN20) was processed by stamping. The microstructure, crystallographic orientation and corrosion performance of this processing method was investigated to reveal the influence of the stamping process on the degradation rate of Rolled Mg-2Zn-Nd (ZN20). The degradation rate was measured by immersion of the Mg-2Zn-0.5Nd alloy in simulated body fluid using Electrochemical Impedance Spectroscopy, Potentiodynamic polarization and mass loss. The in vitro degradation result shows that the degradation rate of the Rolled Mg-2Zn-0.5Nd increased from 0.2 mm/year to 0.5 mm/year after stamping processing. The result reveals that the activation of the 10 1 ‾ 2 tension twin during stamping can remarkably weaken the 0001 basal texture and have a significant influence on the corrosion rate of Stamped Mg-2Zn-0.5Nd sheet. After removing the deformation by annealing, the degradation rate was reduced to 0.15 mm/year. This work is expected to prompt better microstructural design of biomedical Mg in order to control its degradation behavior for biomedical application. © 2020 Production and hosting by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.Background Study populations in clinical research must reflect US changing demographics, especially with the rise of precision medicine. However, racial and ethnic minority groups (REMGs) have low rates of participation in cancer clinical trials. Methods Criteria were developed to identify cancer centers able to accrue a higher than average proportion of REMGs into clinical trials. Comprehensive interviews were conducted with leaders of these cancer centers to identify operational strategies contributing to enhanced accrual of REMGs. Results Eight US cancer centers reported a REMG accrual rate range in cancer research between 10 and 50% in a 12-month reporting period and met other criteria for inclusion. Fourteen leaders participated in this assessment. Key findings were that centers had a metric collection and reporting approach; routinely captured race and ethnicity data within databases accessible to research staff; had operational standards to support access and inclusion; developed practices to facilitate sustained patient participation during clinical trials; had strategies to decrease recruitment time and optimize clinical study design; and identified low-resource strategies for REMG accrual. There was also a clear commitment to establish processes that support the patient's provider as the key influencer of patient recruitment into clinical trials. Conclusion We have identified operational practices that facilitate increased inclusion of REMGs in cancer trials. In order to establish a sustainable cancer center inclusion research strategy, it is valuable to include an operational framework that is informed by leading US cancer centers of excellence. © 2020 The Author(s).Background Data generated by phase I trials is richer than the classical binary DLT measured at the first cycle used as primary endpoints. Several works developed designs for more informative endpoints, e.g. ordinal toxicity grades and/or longitudinal data which relied however on strong assumptions, in particular the proportional odds (PO) assumption. Methods We evaluated this PO assumption for the dose and cycle on a large database of individual patient data from 54 phase I clinical trials of molecularly targeted agents. https://www.selleckchem.com/products/evobrutinib.html The PO model is a specific case of the continuation ratio logit model (CRLM) with null parameters. We compared the PO and CRLM models using the widely applicable information criterion (WAIC). We considered a longitudinal multivariate ordinal toxicity outcome (cutaneous, digestive, hematological, general disorders, and other toxicities). Results WAIC suggested that the CRLM model (WAIC = 30911.58) outperformed the PO model (WAIC = 31432.10). Deviance from PO assumption for dose was observed for digestive and general disorder toxicities. There was moderate cycle effect with slight deviance from PO assumption for the other type of toxicity. Conclusions Designs based on PO for dose should be a useful tool for drug with low expected digestive or general disorder toxicity dose-related incidence. © 2020 The Authors.
© The Korean Urological Association, 2020.A disease-specific biomarker (or biomarkers) is a characteristic reflecting a pathological condition in human body, which can be used as a diagnostic or prognostic tool for the clinical management. A urine-based biomarker(s) may provide a clinical value as attractive tools for clinicians to utilize in the clinical setting in particular to bladder diseases including bladder cancer and other bladder benign dysfunctions. Urine can be easily obtained by patients with no preparation or painful procedures required from patients' side. Currently advanced omics technologies and computational power identified potential omics-based novel biomarkers. An unbiased profiling based on transcriptomics, proteomics, epigenetics, metabolomics approaches et al. found that expression at RNA, protein, and metabolite levels are linked with specific bladder diseases and outcomes. In this review, we will discuss about the urine-based biomarkers reported by many investigators including us and how these biomarkers can be applied as a diagnostic and prognostic tool in clinical trials and patient care to promote bladder health. Furthermore, we will discuss how these promising biomarkers can be developed into a smart medical device and what we should be cautious about toward being used in real clinical setting. © The Korean Urological Association, 2020.Metastatic prostate cancer is a heterogeneous disease entity. Men without prior androgen deprivation therapy exposure are termed metastatic castration sensitive prostate cancer (mCSPC). The goal of this article is to update the reader on the rapidly changing landscape of treatment for men with mCSPC. Along with the options available to the clinician for treatment of men with mCSPC, the care of these patients has evolved into a multi-disciplinary field with expanding roles for medical, urologic, and radiation oncologists. © The Korean Urological Association, 2020.Stamping processing is commonly used to form medical devices and implant. However, for biodegradable Mg alloy, the stamping will influence the degradation behavior because of the change in microstructure after stamping. So in this study, the As-rolled Mg-2Zn-0.5Nd alloy (ZN20) was processed by stamping. The microstructure, crystallographic orientation and corrosion performance of this processing method was investigated to reveal the influence of the stamping process on the degradation rate of Rolled Mg-2Zn-Nd (ZN20). The degradation rate was measured by immersion of the Mg-2Zn-0.5Nd alloy in simulated body fluid using Electrochemical Impedance Spectroscopy, Potentiodynamic polarization and mass loss. The in vitro degradation result shows that the degradation rate of the Rolled Mg-2Zn-0.5Nd increased from 0.2 mm/year to 0.5 mm/year after stamping processing. The result reveals that the activation of the 10 1 ‾ 2 tension twin during stamping can remarkably weaken the 0001 basal texture and have a significant influence on the corrosion rate of Stamped Mg-2Zn-0.5Nd sheet. After removing the deformation by annealing, the degradation rate was reduced to 0.15 mm/year. This work is expected to prompt better microstructural design of biomedical Mg in order to control its degradation behavior for biomedical application. © 2020 Production and hosting by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.Background Study populations in clinical research must reflect US changing demographics, especially with the rise of precision medicine. However, racial and ethnic minority groups (REMGs) have low rates of participation in cancer clinical trials. Methods Criteria were developed to identify cancer centers able to accrue a higher than average proportion of REMGs into clinical trials. Comprehensive interviews were conducted with leaders of these cancer centers to identify operational strategies contributing to enhanced accrual of REMGs. Results Eight US cancer centers reported a REMG accrual rate range in cancer research between 10 and 50% in a 12-month reporting period and met other criteria for inclusion. Fourteen leaders participated in this assessment. Key findings were that centers had a metric collection and reporting approach; routinely captured race and ethnicity data within databases accessible to research staff; had operational standards to support access and inclusion; developed practices to facilitate sustained patient participation during clinical trials; had strategies to decrease recruitment time and optimize clinical study design; and identified low-resource strategies for REMG accrual. There was also a clear commitment to establish processes that support the patient's provider as the key influencer of patient recruitment into clinical trials. Conclusion We have identified operational practices that facilitate increased inclusion of REMGs in cancer trials. In order to establish a sustainable cancer center inclusion research strategy, it is valuable to include an operational framework that is informed by leading US cancer centers of excellence. © 2020 The Author(s).Background Data generated by phase I trials is richer than the classical binary DLT measured at the first cycle used as primary endpoints. Several works developed designs for more informative endpoints, e.g. ordinal toxicity grades and/or longitudinal data which relied however on strong assumptions, in particular the proportional odds (PO) assumption. Methods We evaluated this PO assumption for the dose and cycle on a large database of individual patient data from 54 phase I clinical trials of molecularly targeted agents. https://www.selleckchem.com/products/evobrutinib.html The PO model is a specific case of the continuation ratio logit model (CRLM) with null parameters. We compared the PO and CRLM models using the widely applicable information criterion (WAIC). We considered a longitudinal multivariate ordinal toxicity outcome (cutaneous, digestive, hematological, general disorders, and other toxicities). Results WAIC suggested that the CRLM model (WAIC = 30911.58) outperformed the PO model (WAIC = 31432.10). Deviance from PO assumption for dose was observed for digestive and general disorder toxicities. There was moderate cycle effect with slight deviance from PO assumption for the other type of toxicity. Conclusions Designs based on PO for dose should be a useful tool for drug with low expected digestive or general disorder toxicity dose-related incidence. © 2020 The Authors.
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