Clinical trial NCT06894823: Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)
Official title: Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasm
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Cancer patients
* Patients from the central-southern regions

Exclusion Criteria:

-

Primary outcomes:
measure: Improvement of diagnostic precision in oncology based on advanced molecular profiling tools.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Study officials:
affiliation: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
name: Antonella De Luca
role: PRINCIPAL_INVESTIGATOR
References: