Background: Colorectal cancers are third most common cancer in both genders. They are associated ... more Background: Colorectal cancers are third most common cancer in both genders. They are associated with genetic and environmental factors. Staging is important in the prognosis. Carcinoembryonic Antigen (CEA) provides preliminary information and there is a correlation between Proliferation Index (PI) and prognostic variables. Our aim is to investigate the relationship between DNA repair capacity and clinico-pathologic factors. Patients and Methods: The blood samples taken from cancer patients were irradiated. DNA repair capacity by comet technique was calculated. The CEA values were recorded. Pathology reports were collected and PI values were calculated. sResults: Total of 30 patients; male (n: 14) and female (n: 16) with a median age of 66.37 ± 10.32 were included. Mean CEA value was 42.85 (1.46 - 422.30 μgr/ml) μgr/ml. Mean % DNA repair capacity was 44.49 ± 5.24. In the pathology; 21 (70%) were T3 tumors; 18 (60%) had lymphatic and 12 (40%) had vascular 2 invasion. Perineural invasion was present in 8 (26.7%). According to the proliferation index (PI); 16 (53.3%) were in high percentile (PI > 66%) group. Conclusions: There was a significant correlation between; perineural invasion and tumor grade (P = 0.043); lymphatic and perineural invasion (P = 0.006); lymphatic invasion and vascular invasion (P = 0.034) and the DNA repair capacity with the lymphatic invasion (P = 0.026). There was also a statistically significant (P = 0.044) relationship between PI and lymphatic invasion. As a result in colorectal cancer patients DNA repair capacity can be used as a biomarker in the staging and also in the prediction of the tumor behavior.
In this study, the comet assay was used to evaluate whether welding fume and solvent base paint e... more In this study, the comet assay was used to evaluate whether welding fume and solvent base paint exposure led to DNA damage in construction-site workers in Turkey. The workers (n 1⁄4 52) were selected according to their exposure in the construction site and controls (n 1⁄4 26) from the general population, with no history of occupational exposure. The alkaline comet assay, a standard method for assessing genotoxicity, has been applied in peripheral lymphocytes of all subjects. The mean percentages of DNA in tail (%DNAT) of each group were evaluated, including the comparisons between smokers in each different group and the duration of exposure. Significant increase in the mean %DNAT (p < 0.01) was observed in all exposed subjects (12.34 + 2.05) when compared with controls (6.64 + 1.43). Also %DNAT was significantly high (p < 0.01) in welders (13.59 + 1.89) compared with painters (11.10 + 1.35). There was a statistical meaningful difference in % DNAT between control and exposed sm...
Drug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such ... more Drug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such as artificial intelligence. However, we need new ideas and application contexts for integration of biomarkers and emerging technologies in modern pharmacovigilance. A new concept, panvigilance, has been recently introduced for proactive "stress testing" of new drug candidates in panels of patients or healthy volunteers identified by biomarkers, and who are situated in population edges in terms of pharmacokinetic (PK) and/or molecular target interindividual variability. Panvigilance aims to provide upper and lower bound estimates for drug performance under conditions that mimic population edges. Subsequently, it becomes easier to extrapolate pharmacovigilance signals with regard to individuals who reside in between the population edges. In this expert review, we explain that the prefix "pan," meaning everything or all, refers to the three-pronged panvigilance goals to (1) decipher the full population scale variability in medicinal product PKs and molecular target variability, (2) empower forecasting of pharmacovigilance signals within and across populations through knowledge of biomarker variations worldwide, and (3) integration of pharmacovigilance signals across government ministries, civil society organizations, and other stakeholders through, for example, institutional innovation such as centers for panvigilance. We note that panvigilance and pharmacovigilance are complementary, and underscore the added value of panvigilance for global clinical trials. Panvigilance offers a new opportunity for meaningful biomarker application in clinical trials beyond traditional contexts such as personalized medicine. In sum, panvigilance is a systems approach to pharmacovigilance and poised to innovate risk governance in medicinal product development and clinical trials.
Atherosclerotic coronary artery disease (CAD) appears to be a multifactorial process caused by th... more Atherosclerotic coronary artery disease (CAD) appears to be a multifactorial process caused by the interaction of environmental risk factors with multiple predisposing genes. Therefore, in this study we aimed to determine the role of oxidative DNA damage and some variations in glutathione S-transferase (GSTM1 and GSTT1) and DNA repair (hOGG1) genes in CAD risk. A case-control study was conducted on 59 individuals who had undergone coronary angiographic evaluation. Of these, 29 were patients diagnosed with CAD (mean age =61.5±10.3) and 30 were controls examined for reasons other than suspected CAD and who had angiographically documented normal coronary arteries (mean age =60.4±11.6). Basal DNA damage as well as pyrimidine and purine base damage were evaluated in peripheral blood lymphocytes using the modified comet assay. Polymerase chain reaction-restriction length polymorphism (PCR-RFLP)-based assay was used for genotyping. Basal DNA damage levels in patients [9.16 (3.26)] were sig...
Background: Colorectal cancers are third most common cancer in both genders. They are associated ... more Background: Colorectal cancers are third most common cancer in both genders. They are associated with genetic and environmental factors. Staging is important in the prognosis. Carcinoembryonic Antigen (CEA) provides preliminary information and there is a correlation between Proliferation Index (PI) and prognostic variables. Our aim is to investigate the relationship between DNA repair capacity and clinico-pathologic factors. Patients and Methods: The blood samples taken from cancer patients were irradiated. DNA repair capacity by comet technique was calculated. The CEA values were recorded. Pathology reports were collected and PI values were calculated. sResults: Total of 30 patients; male (n: 14) and female (n: 16) with a median age of 66.37 ± 10.32 were included. Mean CEA value was 42.85 (1.46 - 422.30 μgr/ml) μgr/ml. Mean % DNA repair capacity was 44.49 ± 5.24. In the pathology; 21 (70%) were T3 tumors; 18 (60%) had lymphatic and 12 (40%) had vascular 2 invasion. Perineural invasion was present in 8 (26.7%). According to the proliferation index (PI); 16 (53.3%) were in high percentile (PI > 66%) group. Conclusions: There was a significant correlation between; perineural invasion and tumor grade (P = 0.043); lymphatic and perineural invasion (P = 0.006); lymphatic invasion and vascular invasion (P = 0.034) and the DNA repair capacity with the lymphatic invasion (P = 0.026). There was also a statistically significant (P = 0.044) relationship between PI and lymphatic invasion. As a result in colorectal cancer patients DNA repair capacity can be used as a biomarker in the staging and also in the prediction of the tumor behavior.
In this study, the comet assay was used to evaluate whether welding fume and solvent base paint e... more In this study, the comet assay was used to evaluate whether welding fume and solvent base paint exposure led to DNA damage in construction-site workers in Turkey. The workers (n 1⁄4 52) were selected according to their exposure in the construction site and controls (n 1⁄4 26) from the general population, with no history of occupational exposure. The alkaline comet assay, a standard method for assessing genotoxicity, has been applied in peripheral lymphocytes of all subjects. The mean percentages of DNA in tail (%DNAT) of each group were evaluated, including the comparisons between smokers in each different group and the duration of exposure. Significant increase in the mean %DNAT (p < 0.01) was observed in all exposed subjects (12.34 + 2.05) when compared with controls (6.64 + 1.43). Also %DNAT was significantly high (p < 0.01) in welders (13.59 + 1.89) compared with painters (11.10 + 1.35). There was a statistical meaningful difference in % DNAT between control and exposed sm...
Drug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such ... more Drug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such as artificial intelligence. However, we need new ideas and application contexts for integration of biomarkers and emerging technologies in modern pharmacovigilance. A new concept, panvigilance, has been recently introduced for proactive "stress testing" of new drug candidates in panels of patients or healthy volunteers identified by biomarkers, and who are situated in population edges in terms of pharmacokinetic (PK) and/or molecular target interindividual variability. Panvigilance aims to provide upper and lower bound estimates for drug performance under conditions that mimic population edges. Subsequently, it becomes easier to extrapolate pharmacovigilance signals with regard to individuals who reside in between the population edges. In this expert review, we explain that the prefix "pan," meaning everything or all, refers to the three-pronged panvigilance goals to (1) decipher the full population scale variability in medicinal product PKs and molecular target variability, (2) empower forecasting of pharmacovigilance signals within and across populations through knowledge of biomarker variations worldwide, and (3) integration of pharmacovigilance signals across government ministries, civil society organizations, and other stakeholders through, for example, institutional innovation such as centers for panvigilance. We note that panvigilance and pharmacovigilance are complementary, and underscore the added value of panvigilance for global clinical trials. Panvigilance offers a new opportunity for meaningful biomarker application in clinical trials beyond traditional contexts such as personalized medicine. In sum, panvigilance is a systems approach to pharmacovigilance and poised to innovate risk governance in medicinal product development and clinical trials.
Atherosclerotic coronary artery disease (CAD) appears to be a multifactorial process caused by th... more Atherosclerotic coronary artery disease (CAD) appears to be a multifactorial process caused by the interaction of environmental risk factors with multiple predisposing genes. Therefore, in this study we aimed to determine the role of oxidative DNA damage and some variations in glutathione S-transferase (GSTM1 and GSTT1) and DNA repair (hOGG1) genes in CAD risk. A case-control study was conducted on 59 individuals who had undergone coronary angiographic evaluation. Of these, 29 were patients diagnosed with CAD (mean age =61.5±10.3) and 30 were controls examined for reasons other than suspected CAD and who had angiographically documented normal coronary arteries (mean age =60.4±11.6). Basal DNA damage as well as pyrimidine and purine base damage were evaluated in peripheral blood lymphocytes using the modified comet assay. Polymerase chain reaction-restriction length polymorphism (PCR-RFLP)-based assay was used for genotyping. Basal DNA damage levels in patients [9.16 (3.26)] were sig...
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