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NCT Number: NCT06894823

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale

Naples, 80131, Italy

Location status: Recruiting

Location contact

Antonella De Luca

CONTACT

[email protected]

08117770603

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cancer patients
  • Patients from the central-southern regions

Exclusion criteria

-

Treatment and study plan

Creation of a laboratory network

Other

Creation of a laboratory network in Central-Southern Italy capable of performing complex genomic analyses.

Mapping of genomic alterations

Other

Mapping of genomic alterations aimed at precision medicine and personalized diagnostic and therapeutic approaches.

Creation of a bioinformatics network among the participating institutions.

Other

Creation of a bioinformatics network among the participating institutions.

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

Other

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

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

Other

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

Primary outcomes

  1. Improvement of diagnostic precision in oncology based on advanced molecular profiling tools.

    Time frame: 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella De Luca

CONTACT

[email protected]

08117770603

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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