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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm
• Intervention / Treatment: Other: Creation of a laboratory network; Other: Mapping of genomic alterations; Other: Creation of a bioinformatics network among the participating institutions.; Other: 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.

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.

• Study Type: Observational
• Enrollment (Estimated): 16000

Contacts and Locations

• Study Contact: Name: Antonella De Luca; Phone Number: 08117770603; Email: a.deluca@istitutotumori.na.it

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
    • Contact: Antonella De Luca; Phone Number: 08117770603; Email: a.deluca@istitutotumori.na.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients from the central-southern regions of Italy diagnosed with lung, breast, colorectal, ovarian, liver, bile duct, pancreatic, and gastric cancers.

Description

Inclusion Criteria:

• Cancer patients
• Patients from the central-southern regions

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of diagnostic precision in oncology based on advanced molecular profiling tools.	4 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Antonella De Luca, Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: COESIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No