NCT06894823

Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16,000 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

COESIT aims to establish a network of reference laboratories in the central-southern regions of Italy for the genetic and molecular characterization of tumors, with the goal of implementing precision and personalized oncology in clinical practice.

Detailed description

The project will begin with a technological upgrade of the laboratories and the standardization of sequencing procedures and bioinformatics analyses, involving all institutions participating in the initiative. Subsequently, a shared database will be created, integrating sequencing data and clinicopathological information. This will enable research projects aimed at expanding knowledge on the genetic alterations of tumors in patients from central-southern Italy and identifying prognostic and predictive biomarkers that support the implementation of precision and personalized medicine. The enhancement of genomic laboratories, the sharing of analytical procedures and bioinformatics protocols, and the development of a common database of sequencing and clinicopathological data will serve as essential tools to deepen specific knowledge on the genomic characteristics of tumors in patients from southern Italy. This will facilitate the clinical implementation of precision and personalized medicine based on genomic analysis. The study is multicentric and observational. The nature of the data included will be both retrospective and prospective, as described below: 1. Prospective collection of clinicopathological information, including lifestyle factors and exposure to environmental and occupational carcinogens, as well as CGP (Comprehensive Genomic Profiling) data obtained through targeted sequencing techniques. These data will be generated within clinical practice or local genomic screening programs, with the patient's informed consent. 2. Analysis of the correlation between tumor heterogeneity-specifically genomic biomarkers-and therapy response in all enrolled patients who did not respond to targeted therapy administered according to current clinical guidelines. 3. Retrospective collection of clinicopathological information and CGP data from case series available in COESIT center biobanks for the identification of new biomarkers. Specific sub-studies will be proposed with amendments to the main study described here. 4. Collection of information on germline alterations in individuals at risk for breast and gastric cancer, already analyzed within approved protocols , with the subject's informed consent for data inclusion in the COESIT platform.

Conditions

• Neoplasm

Interventions

Type	Name	Description
OTHER	Creation of a laboratory network	Creation of a laboratory network in Central-Southern Italy capable of performing complex genomic analyses.
OTHER	Mapping of genomic alterations	Mapping of genomic alterations aimed at precision medicine and personalized diagnostic and therapeutic approaches.
OTHER	Creation of a bioinformatics network among the participating institutions.	Creation of a bioinformatics network among the participating institutions.
OTHER	Development of a platform for the collection of clinicopathological and genetic-molecular data.	Development of a platform for the collection of clinicopathological and genetic-molecular data.
OTHER	Identification of prognostic and predictive factors for the implementation of precision oncology strategies based on genomic profiling.	Identification of prognostic and predictive factors for the implementation of precision oncology strategies based on genomic profiling.

Timeline

• Start date: 2024-12-10
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: Italy