INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP) (IT-TCP POS)

February 13, 2026 updated by: Giovanni Roti, Azienda Ospedaliero-Universitaria di Parma
This is a multicenter, experimental preclinical study conducted on primary samples from patients diagnosed with hematological or solid neoplasms defined as high risk. The study will be prospective, based on the consecutive enrollment of eligible patients at each participating institution.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This pre-clinical, experimental study will involve primary samples from patients diagnosed with haematological or solid neoplasms defined as high-risk.

It will be prospective, based on consecutive enrolment of eligible patients at each participating institution. Patients will be enrolled based on their biological and clinical characteristics at the time of diagnosis. This will include patients with metastatic disease, as well as those with recurrent or refractory disease, particularly where the therapeutic indication is not supported by internationally recognised guidelines.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Palermo
      • Palermo, Palermo, Italy, 90146
        • Recruiting
        • AO Riuniti Villa Sofia-Cervello di Palermo
        • Contact:
    • Perugia
      • Perugia, Perugia, Italy, 06123
        • Recruiting
        • University Of Perugia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients aged one year and over who are referred to the centres involved in the protocol (Azienda Ospedaliero-Universitaria di Parma, University of Parma, University of Perugia and Azienda Ospedali Riuniti Villa Sofia-Cervello of Palermo).
  • Patients with an established diagnosis of haematological or solid organ malignancy, including haematological or solid malignancies characteristic of the paediatric age group.
  • Patients diagnosed with relapsed, refractory and/or metastatic haematological or solid malignancy. Patients may be enrolled regardless of the extent and type of previous therapy. Patients may also be enrolled if they are undergoing active treatment at the time of evaluation.
  • Patients must have the capacity to understand the investigative nature of the study and provide informed consent in writing. For patients under the age of 12 years, consent will be provided by the parent/legal guardian according to international guidelines. For patients aged 12 to 17 years, consent will be provided by the patient and the parent/legal guardian according to the mature minor principle.

Exclusion criteria:

  • Patients younger than 1 year old
  • Patients with active, uncontrolled infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Haematological neoplasms or neoplasms of solid organs
  • Patients with a confirmed diagnosis of hematological malignancy or solid organ malignancy, including solid or hematological malignancies characteristic of pediatric age.
  • Patients diagnosed with hematological or solid neoplasms defined as high risk, according to biological and clinical characteristics, including metastatic cases, or diagnosed with recurrent and/or refractory hematological or solid neoplasms.
Biological: Functional tests
Functional analyses will be performed on primary sample from each enrolled patient. Malignant cells are cultered and incubated with a specific library of drugs (300 drugs) at four different concentrations for 72 hours.
Other: Multi-omics analyses
Our scientific approach is based on various investigations, including radiomics, digital pathology, immune profiling, bulk transcriptomics, single-cell resolution, single-cell transcriptomics, phosphoproteomics, functional immunoprofiling, and inflammasome analysis, NGS (Next Generation Sequencing analysis).
Genetic: Cytogenetics/ FISH
Individual biopsy samples will be evaluated in a pipeline that includes established diagnostic elements, e.g., cytogenetics and FISH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.
Time Frame: At baseline
At baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the possible use of the IT-TCP platform on the clinical level
Time Frame: At baseline
At baseline
Creation of an IT platform to store and manage the data generated
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 12, 2028

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5756

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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