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Observational Study on Thyroid Tumors and EvaLuation of the roLe of New pOntential Predictive/Prognostic Factors

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

The OTELLO Study is a monocentric, ambispective observational study that systematically analyzes the clinical, laboratory, anatomopathological, and molecular characteristics of patients with thyroid neoplasms treated at the Agostino Gemelli University Hospital - IRCCS. Study Objectives The primary goal is to identify prognostic and predictive factors that can enhance the clinical and therapeutic management of thyroid cancer patients at any disease stage. The analysis aims to integrate biological tumor characteristics with clinical and therapeutic data to identify significant correlations between these parameters and disease progression. Study Design and Patient Cohorts The study includes two distinct cohorts: Historical (retrospective) cohort: This group includes patients previously treated for thyroid neoplasms from January 1, 2010, to the date of study approval. Data from these patients will be analyzed to evaluate long-term outcomes and identify potential predictors of treatment response. Prospective cohort: This group includes patients newly diagnosed with thyroid cancer who will be enrolled over a 60-month period from the study's approval. These patients will undergo systematic monitoring to assess disease progression and therapy effectiveness. Data Collection and Analysis The study will collect and examine data on: Clinical characteristics: Including sex, age at diagnosis, comorbidities, hereditary syndromes, and performance status. Laboratory data: Including tumor markers and metabolic parameters relevant to disease characterization. Anatomopathological aspects: Such as histological tumor type, pathological staging, lymphovascular or perineural invasion, and other indicators of tumor aggressiveness. Molecular profiles: Evaluated through genetic alterations and biomarkers with potential prognostic and predictive value. Statistical and Methodological Approach An advanced statistical approach will be used to assess the impact of collected variables on patient outcomes. The analysis will include: Comparative analyses of patient groups based on clinical and biological characteristics. Survival analysis, estimating overall survival (OS) and progression-free survival (PFS) using Kaplan-Meier curves and log-rank tests. Multivariate regression models to identify independent factors associated with prognosis and treatment response. Ethical Considerations and Regulatory Compliance The study will be conducted in compliance with ethical and regulatory guidelines, including the Declaration of Helsinki, Good Clinical Practice (GCP) by ICH, and Italian regulations on observational studies. Patient data will be anonymized and securely stored, ensuring confidentiality. As a non-interventional study, no experimental drugs or procedures will be administered. However, molecular and immunohistochemical analyses will be performed on tumor tissue samples already available or collected during standard clinical practice. Study Timeline and Expected Outcomes The prospective cohort enrollment will continue until 2029, after which statistical analyses will be completed, and study results will be published. The collected data will provide valuable insights for optimizing the clinical management of thyroid cancer patients, supporting the development of increasingly personalized diagnostic and therapeutic strategies.

Official title: Observational Study on the Clinical, Laboratory, Anatomopathological, and Molecular Characteristics and Their Prognostic and Predictive Value in Patients With Thyroid Tumors Treated at the Fondazione Policlinico Universitario A.Gemelli IRCCS.

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