Validation Control

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Rita Martins Pontes - One of the best experts on this subject based on the ideXlab platform.

  • certificacao iso 22000 validacao de medidas de Controlo em producao de pastelaria salgada
    2010
    Co-Authors: Rita Martins Pontes
    Abstract:

    The Validation of Control measures is an essencial step in the development of a food safety management system, since it is through the Validation process that one demonstrates that the selected Control measures are actually capable of achieving the intended level of hazard Control. Amongst the microorganisms that can be found in the various raw materials used in salty pastry production, those most frequently associated with foodborne illness in industrialized countries include Salmonella spp., Staphylococcus aureus, Clostridium perfringens, Vibrio parahaemolyticus, and Campylobacter spp. Typically, the vegetative forms of the pathogenic microorganisms of concern are easily destroyed at pasteurization temperatures. On the other hand, spores and the majority of bacterial toxins are more resistent to thermal treatments, requiring temperatures above 100°C to be destroyed. The products discussed in the present work comprise meat croquettes and pasties, shrimp and vegetable pasties, chicken pies and codfish cakes. Throughout the pasties production, the fillings undergo thermal treatments that can be compared to a pasteurization process, reaching temperatures above 70°C for at least two minutes. The time fillings remain in the production room is also monitored, and it has to be less than two hours. This assures that the filling’s temperature does not remain in the critical zone for microbial multiplication (60°C to 10°C) long enough to allow bacterial spores to germinate and grow. Thus it has been demonstraded that the thermal processes and the monitored cooling of the fillings are capable of Controlling the development of pathogenic microorganisms in the analysed products. Key-words: Validation; Control measures; potentially pathogenic microorganisms; salty pastry; pasteurization; cooling.

Maria Teresa Fierro - One of the best experts on this subject based on the ideXlab platform.

  • TERT Promoter Mutations are Associated with Visceral Spreading in Melanoma of the Trunk
    MDPI AG, 2019
    Co-Authors: Simona Osella-abate, Luca Bertero, Rebecca Senetta, Sara Mariani, Francesco Lisa, Vittoria Coppola, Jasna Metovic, Barbara Pasini, Susana Puig S, Maria Teresa Fierro
    Abstract:

    Survival predictions are currently determined on the basis of NRAS/BRAF mutations, even though TERT promoter mutations have been recently associated with a poor prognosis in stage I-II melanomas. Usually, it is not recommended to perform a mutational test on primary melanoma, as the results do not always reflect the mutational status of metastases. In particular, trunk melanomas have been reported to have an unfavourable prognosis. A series of 105 advanced melanoma patients were analysed by TERT promoter Sanger sequencing. Univariate/multivariate binary logistic regression models were performed using progression to a visceral site as the dependent variable and patient/tumour characteristics as covariates. Performance of the model was assessed in an external independent primary melanoma patients’ dataset. Male gender (odds ratio (OR), 344; 95% CI, 1.12–10.6; p = 0.031), AJCC (American Joint Committee on Cancer) classification (OR, 022; 95% CI, 0.07–0.67; p = 0.008), SLNB (Sentinel Lymph Node Biopsy) status (OR, 3.05; 95% CI, 1.06–8.78; p = 0.039) and TERT-mutated trunk lesions (OR, 3.78; 95% CI, 1.35–10.6; p =  0.011) were significantly associated with the risk of developing a visceral spreading as first site of progression using multivariate logistic regression analysis. These results were confirmed in the external Validation Control group. Therefore, in trunk primary melanomas, due to their high risk of progression to visceral sites, we encourage somatic TERT mutation analysis at diagnosis to identify those patients who would potentially benefit from a more intensive follow-up protocol and a prompt initiation of therapy

Simona Osella-abate - One of the best experts on this subject based on the ideXlab platform.

  • TERT Promoter Mutations are Associated with Visceral Spreading in Melanoma of the Trunk
    MDPI AG, 2019
    Co-Authors: Simona Osella-abate, Luca Bertero, Rebecca Senetta, Sara Mariani, Francesco Lisa, Vittoria Coppola, Jasna Metovic, Barbara Pasini, Susana Puig S, Maria Teresa Fierro
    Abstract:

    Survival predictions are currently determined on the basis of NRAS/BRAF mutations, even though TERT promoter mutations have been recently associated with a poor prognosis in stage I-II melanomas. Usually, it is not recommended to perform a mutational test on primary melanoma, as the results do not always reflect the mutational status of metastases. In particular, trunk melanomas have been reported to have an unfavourable prognosis. A series of 105 advanced melanoma patients were analysed by TERT promoter Sanger sequencing. Univariate/multivariate binary logistic regression models were performed using progression to a visceral site as the dependent variable and patient/tumour characteristics as covariates. Performance of the model was assessed in an external independent primary melanoma patients’ dataset. Male gender (odds ratio (OR), 344; 95% CI, 1.12–10.6; p = 0.031), AJCC (American Joint Committee on Cancer) classification (OR, 022; 95% CI, 0.07–0.67; p = 0.008), SLNB (Sentinel Lymph Node Biopsy) status (OR, 3.05; 95% CI, 1.06–8.78; p = 0.039) and TERT-mutated trunk lesions (OR, 3.78; 95% CI, 1.35–10.6; p =  0.011) were significantly associated with the risk of developing a visceral spreading as first site of progression using multivariate logistic regression analysis. These results were confirmed in the external Validation Control group. Therefore, in trunk primary melanomas, due to their high risk of progression to visceral sites, we encourage somatic TERT mutation analysis at diagnosis to identify those patients who would potentially benefit from a more intensive follow-up protocol and a prompt initiation of therapy

Youngil Koh - One of the best experts on this subject based on the ideXlab platform.

  • oncogenic effects of germline mutations in lysosomal storage disease genes
    bioRxiv, 2018
    Co-Authors: Junghoon Shin, Murim Choi, Sung-soo Yoon, Daeyoon Kim, Hyunglae Kim, Jan O Korbel, Youngil Koh
    Abstract:

    Clinical observations have indicated that patients with Gaucher disease or Fabry disease are at increased risk of cancer. However, a systematic evaluation of the oncogenic effects of causal mutations of lysosomal storage diseases (LSDs) has been lacking. Here we report a comprehensive association analysis between potentially pathogenic germline mutations in LSD genes and cancer interrogating genomic (or exomic) variant datasets derived from the Pan-Cancer Analysis of Whole Genomes project (case cohort), the 1000 Genomes project (primary Control cohort), and the Exome Aggregation Consortium that does not include The Cancer Genome Atlas subset (Validation Control cohort). We show that potentially pathogenic variants (PPVs) in 42 LSD genes are significantly enriched in cancer patients in a histology-dependent manner, cancer risk is higher in individuals with a greater number of PPVs, and cancer develops earlier in PPV carriers. Analysis of tumor genomic and transcriptomic data from the pancreatic adenocarcinoma cohort revealed potential mechanisms that might be involved in the oncogenic contribution of PPVs. Our findings extend the mechanistic understanding of inherited cancer susceptibility and highlight the promise of harnessing available therapeutic strategies to restore lysosomal function for personalized cancer prevention.

Sara Mariani - One of the best experts on this subject based on the ideXlab platform.

  • TERT Promoter Mutations are Associated with Visceral Spreading in Melanoma of the Trunk
    MDPI AG, 2019
    Co-Authors: Simona Osella-abate, Luca Bertero, Rebecca Senetta, Sara Mariani, Francesco Lisa, Vittoria Coppola, Jasna Metovic, Barbara Pasini, Susana Puig S, Maria Teresa Fierro
    Abstract:

    Survival predictions are currently determined on the basis of NRAS/BRAF mutations, even though TERT promoter mutations have been recently associated with a poor prognosis in stage I-II melanomas. Usually, it is not recommended to perform a mutational test on primary melanoma, as the results do not always reflect the mutational status of metastases. In particular, trunk melanomas have been reported to have an unfavourable prognosis. A series of 105 advanced melanoma patients were analysed by TERT promoter Sanger sequencing. Univariate/multivariate binary logistic regression models were performed using progression to a visceral site as the dependent variable and patient/tumour characteristics as covariates. Performance of the model was assessed in an external independent primary melanoma patients’ dataset. Male gender (odds ratio (OR), 344; 95% CI, 1.12–10.6; p = 0.031), AJCC (American Joint Committee on Cancer) classification (OR, 022; 95% CI, 0.07–0.67; p = 0.008), SLNB (Sentinel Lymph Node Biopsy) status (OR, 3.05; 95% CI, 1.06–8.78; p = 0.039) and TERT-mutated trunk lesions (OR, 3.78; 95% CI, 1.35–10.6; p =  0.011) were significantly associated with the risk of developing a visceral spreading as first site of progression using multivariate logistic regression analysis. These results were confirmed in the external Validation Control group. Therefore, in trunk primary melanomas, due to their high risk of progression to visceral sites, we encourage somatic TERT mutation analysis at diagnosis to identify those patients who would potentially benefit from a more intensive follow-up protocol and a prompt initiation of therapy