NCT06894823

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2024Dec 2028

Study Start

First participant enrolled

December 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

March 13, 2025

Last Update Submit

March 19, 2025

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (1)

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

    4 years

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Cancer patients
  • Patients from the central-southern regions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Antonella De Luca

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella De Luca

CONTACT

08117770603a.deluca@istitutotumori.na.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 25, 2025

Study Start

December 10, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

IT(1)