NeoplasmNCT06894823
Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)
An observational study of Neoplasm, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm
- What is being tested?
- Creation of a laboratory network, Mapping of genomic alterations and Creation of a bioinformatics network among the participating institutions.
- How many people
- 16,000 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer patients from the central-southern regions of Italy diagnosed with lung, breast, colorectal, ovarian, liver, bile duct, pancreatic, and gastric cancers.
Who may be able to join
- Cancer patients
- Patients from the central-southern regions
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, 80131
Antonella De Luca, 08117770603, a.deluca@istitutotumori.na.it
About this study
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.
Read the 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:
- 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.
- Conditions
- Neoplasm
- Being tested
- Creation of a laboratory network, Mapping of genomic alterations, Creation of a bioinformatics network among the participating institutions., 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.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creation of a laboratory networkOther
Creation of a laboratory network in Central-Southern Italy capable of performing complex genomic analyses.
Mapping of genomic alterationsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of diagnostic precision in oncology based on advanced molecular profiling tools.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start10 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonella De Luca, Principal investigator, Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894823
- Sponsor's protocol ID
- COESIT
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)
- ClinicalTrials.gov ID
- NCT06894823
- Acronym / sponsor ID
- COESIT
- Conditions
- Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients from the central-southern regions of Italy diagnosed with lung, breast, colorectal, ovarian, liver, bile duct, pancreatic, and gastric cancers.
Key inclusion criteria (2 listed)
- Cancer patients
- Patients from the central-southern regions
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creation of a laboratory networkCreation of a laboratory network in Central-Southern Italy capable of performing complex genomic analyses. | Other | – |
| Mapping of genomic alterationsMapping of genomic alterations aimed at precision medicine and personalized diagnostic and therapeutic approaches. | Other | – |
| Creation of a bioinformatics network among the participating institutions.Creation of a bioinformatics network among the participating institutions. | Other | – |
| Development of a platform for the collection of clinicopathological and genetic-molecular data.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.Identification of prognostic and predictive factors for the implementation of precision oncology strategies based on genomic profiling. | Other | – |
Primary outcome
Improvement of diagnostic precision in oncology based on advanced molecular profiling tools.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonella De Luca principal investigator
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella De Luca (08117770603, a.deluca@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of diagnostic precision in oncology based on advanced molecular profiling tools. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.