LINE 3: PERSONALIZED AND GENDER MEDICINE IN ONCOLOGY
This line of research aims to develop and apply new approaches of personalized medicine based on the biological and molecular characteristics of cancer and the spread of Gender Medicine models in the field of oncology. Thus, basic research in molecular biology will be included allowing a better characterization of pathogenetic and tumor progression mechanisms, a greater understanding of tumor heterogeneity at both the intra- and inter-individual levels, as well as facilitating the development of therapies tailored to the individual. Molecular diagnostics draws on the integration of different approaches such as the use of liquid biopsy, which together with the molecular profile of the primary tumor, allows a sensitive and noninvasive analysis of circulating tumor cells, circulating DNA (ctDNA) and circulating tumor RNAs (miRNA, circRNA,etc) which ultimately monitors, modifies, and develops new therapies based on the use of agents that can specifically interfere with cellular pathways responsible for tumor growth, survival, and progression. Precision medicine also covers clinical trials, pre-clinical and clinical research projects, and initiatives in health care that assess gender differences not only from a biological understanding but also socio-cultural differences between men and women that may influence one’s health and disease status. Indeed, in the field of oncology, sex and gender conditions the development and course of neoplasia, but also the efficacy and safety of neoplastic treatments, in addition to adherence to diagnostic-therapeutic pathways. Although many gender differences have been described in oncology, women still remain the most underrepresented gender type in clinical trials, so the participation of women in clinical trials must be implemented and any gender differences must be focused on both in daily clinical practice and the development of guidelines. The use of therapies that are increasingly tailored to the specific tumor characteristics, clinical history, and biological and sociocultural factors of the patient(s) allow for greater efficacy by reducing the toxicity of anticancer treatments in addition to offering the best therapy at a given time in the disease, consequently improving the quality of care. Implementing new models of personalized and gender-responsive therapy will require technological investments, research focused on improving molecular diagnostics at the omics level, appropriate bio-informatics support, implementing multidisciplinary teams such as Molecular Tumor Boards, creating network collaborations and resources for preclinical and clinical projects to better understand gender differences.
The general objectives of this research line are: enhancing and developing molecular diagnostics and molecular-targeted therapy of cancers and seeking genetic and epigenetic alterations predictive of response to targeted biological therapies, within the setting of personalized medicine; promoting and supporting pre-clinical and clinical research on gender differences so that the knowledge and innovations arising from them can be applied in clinical practice for the dissemination of Gender Medicine Specific Objectives implementing the use of technologies for molecular profiling of tumors that can identify genetic and epigenetic alterations that can be used as molecular targets through the use of gene panels of increasing complexity, RNA seq, WES, WGS. Developing clinical-translational research projects focused on tracking the molecular evolution of neoplasms in both the tissue and the blood allows to identify mechanisms of resistance. Developing standardized and reproducible methods in bio-banking tumor tissue samples and biological fluids. Utilizing the Institute’s Molecular Tumour Board for advanced molecular investigations that can be used in clinical practice as personalized therapeutic recommendations. Enrolling patients in institutional and multicenter clinical trials in innovative personalized therapies and specific patient subpopulations. Developing research projects at the pre-clinical and clinical stages to study gender differences in oncology. Participating in delivering extension guidelines for gender medicine in oncology.
Indicator: Participating in national and international conferences as invited speakers - Organizing seminars and conferences regarding personalized medicine and Gender Medicine - Enrolling patients in clinical trials on innovative personalized therapies and specific patient subpopulations – Collaborating with other facilities and agencies for the development gender specific medicine – Submitting applications and receiving competitive Grants - Publishing Guidelines.