Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and...
BRCA1 Gene MutationBRCA2 Gene Mutation18 moreThis phase II trial studies how well pembrolizumab works in treating participants with cancer that has spread to other places in the body, has come back or has spread to nearby tissues or lymph nodes. Monoclonal antibodies such as, pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
Mutational Oncology in Clinical Practice
Genome InstabilityGenetic Predisposition to Disease1 moreThe study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs. Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability
Metabolic SyndromeTo achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on genomic stability using noble assays. The investigators propose to study the ability of bioactive plant-based food (Nutrition bar made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (> 50 years, men and postmenopausal women) with and without metabolic syndrome.
Safety of Ginkgo Biloba Leaf Extract
HealthyPrimary objective: The primary objective of this study is to assess the effect of Ginkgo biloba L. leaf extract (IDN 5933) in comparison to placebo in human subjects treated at therapeutic doses for 6 months on the level of DNA damage and genomic instability, measured with the Comet Assay and the Micronucleus assay, respectively . Secondary objective: The secondary objective of this study is to provide a preliminary assessment of the safety of Ginkgo biloba L. leaf extract (IDN 5933) in human subjects treated at therapeutic doses in term of adverse drug reaction, hepatotoxicity, genotoxicity.
Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants
AnemiaIron-deficiencyThis study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. One third of the infants that are exclusively breast fed will not receive iron, the second third will receive iron weekly and the last third will receive iron daily. Half of the infants that take infant formula will receive iron weekly and the other half will receive iron daily.
Genomic Instability in Vascular Surgeons
Cytogenetic AbnormalityRadiation ExposureThe past two decades have witnessed the development and growth of the endovascular techniques, however, this new technology is not exempt from risks, since its use requires an ionizing radiation exposure to both patients and surgeons. In this context, the long-term repercussion of this type of chronic exposure to low dose ionizing radiation of the vascular surgeons is still unknown. Although conventional dosimetry is used to monitoring the occupational radiation exposure, it doesn't take into consideration a number of individual variables such as: age, sex, exposure to other carcinogen substances or previous medical history; that may affect the radio-sensibility of each individual. Some studies suggest the use of routine cytogenetic analysis to complement the conventional dosimetry, yet the real genomic effects of chronic low dose ionizing radiation exposure is still unclear and an ideal biodosimetry marker hasn't been described. In this setting, the main objective of the present study was to determine the genomic instability associated to the chronic low dose exposure to ionizing radiation of vascular surgeons versus healthy control patients with no history of radiation exposure. The secondary endpoints were to determine the impact of demographic and clinical practice activities associated to genomic instability among both groups of patients. National, observational and transversal case control study of genomic instability among vascular surgeons chronically exposed to low dose ionizing radiation compared to healthy control patients with no previous history of radiation exposure. The peripheral blood samples of the case group were collected from vascular surgeons during the VI International Symposium of Endovascular Surgery. The blood samples were followed by a demographic and endovascular practice questionnaire. On the other hand, the samples for the control group were collected from healthy patients undergoing saphenectomy and/or phlebectomy in our department at Hospital Clínico Universitario de Valladolid. All blood samples were send to the Cancer Investigation Center at Salamanca University where three types of genomic analysis were performed: (1) fluorescence in situ hybridization (FISH) study in interphase for the chromosomes 3, 7 and 17 and locus 9p21; (2) metaphase study with G banding technique; and (3) sister chromatid exchange (SCE) metaphase study.
Does Sevoflurane Cause Genomic Damage
Anesthesia; Adverse EffectThis study aims to find out if sevoflurane causes any cell damage to patients undergoing general anaesthesia. In case of any damage, the reversibility of the damage is also assessed. This is a prospective, comparative study carried out in all children scheduled for surgical repair of cleft lip or palate admitted in the Department of Plastic Surgery under Smile Train organisation ìn our hospital,who satisfy the inclusion and exclusion criteria.