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

National Cancer Institute, Naples

Status

Enrolling

Conditions

Neoplasm

Treatments

Other: Creation of a bioinformatics network among the participating institutions.

Other: Mapping of genomic alterations

Other: Identification of prognostic and predictive factors for the implementation of precision oncology strategies based on genomic profiling.

Other: Creation of a laboratory network

Other: Development of a platform for the collection of clinicopathological and genetic-molecular data.

Study type

Observational

Funder types

Other

Identifiers

NCT06894823

COESIT

Details and patient eligibility

About

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.

Full 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:

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.
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.
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.
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.

Enrollment

16,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria