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G-DEFINER Clinical Study Protocol

Miceli, Rosalba


Project: "Gender Difference in sidE eFfects of ImmuNotherapy: a possible clue to optimize cancEr tReatment"
(G-DEFINER). Clinical study protocol.

This is a multicenter observational prospective clinical study aimed at investigating the inequalities between female (F) and male (M) patients in the development of immune-related adverse events (irAEs) associated with immunotherapy treatment. The evaluation of the differences in terms of irAEs incidence concerning biological aspects will be integrated by the exploration of their gender dimension.

In common feeling, sex and gender  represent the same concept, that is the traditional division of individuals into F and M defined by differential organization of chromosomes, reproductive organs, and sex steroid levels. Sex influences the adaptive immunity, and may influence irAEs types, frequency and severity. However, if we go beyond these aspects, which characterize “sex”, we can see that the differences between individuals are also characterized by behaviors and relationships that are the product of the culture and sociality. This is what is called "gender", i.e. the process of social and cultural construction that determines the behaviors that give life to the status of an individual. Gender is therefore learned and not innate. Sex and gender do not constitute two opposing but interdependent dimensions: the process of determining gender identity is triggered on biological characters. In patients with cancer, the increasing use of immunotherapic treatments is associated with irAEs caused by non-specific activation of the immune system. Along with sex differences, the study will also explore the irAEs incidence in relation to psychosocial and behavioral determinants, such as: marital status, ethnicity, employment status, level of education, living arrangement, income, smoking condition, alcohol consumption, levels of physical activity, obesity, dietary habits, distress and health status (the latter measured by means of appropriate questionnaires).

The study will also perform gene-expression analysis (blood samples will be taken in order to identify immune-related genes in patients with various solid tumors treated with immunotherapic agents associated with the development of irAEs), SNPs analysis (blood samples will be taken in order to perform a preliminary genome wide association study for the identification of germline variations associated with the development of irAEs. with the hypothesis that the individual’s genetic makeup may be related to irAEs), microbioma analysis (stool collection will be performed to analyze gut microbiota aiming at performing RNA/DNA sequencing analysis for identifying components associated with the development of irAEs).

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