Actively Recruiting

All Genders
ID06894823

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

Led by National Cancer Institute, Naples · Updated on 2025-03-25

16000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are working to establish a network of reference laboratories in the central-southern regions of Italy to improve the genetic and molecular understanding of tumors. The goal is to support the use of precision and personalized oncology in clinical practice by studying tumor genetics and identifying important biomarkers that may guide treatment decisions. The project involves upgrading laboratory technology and standardizing procedures for sequencing and bioinformatics across participating institutions. A shared database will be created to combine genetic sequencing data with clinical and pathological information. This will include both retrospective and prospective data collection, such as patients' lifestyle and environmental exposures, genetic profiles of tumors, and germline alterations in individuals at risk for breast and gastric cancers. Participants will provide informed consent for the collection and analysis of their clinicopathological and genomic data. Researchers will analyze correlations between tumor genetics and therapy response, especially in patients who did not respond to targeted treatments. The main outcome measured is the improvement of diagnostic precision in oncology using advanced molecular profiling over a four-year period. This observational, multicenter study allows researchers to deepen knowledge of tumor genetics and support precision medicine in the region.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cancer patients
  • Patients from the central-southern regions
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Ongoing during clinical care

Participants undergo comprehensive genomic profiling and collection of clinicopathological information as part of routine clinical practice or local genomic screening programs.

Visits as part of routine healthcare

Long-term Monitoring

Duration - Up to 4 years

Participants who undergo routine care are observed for correlation between genomic biomarkers and therapy response, and for identification of new prognostic and predictive factors.

Visits aligned with clinical follow-up schedules

Trial Site Locations

Total: 1 location

1

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

Naples, Italy, 80131

Actively Recruiting

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Research Team

A

Antonella De Luca

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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