INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)
IT-TCP POS
1 other identifier
interventional
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
2 active sites
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 Start
First participant enrolled
May 31, 2023
CompletedFirst Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 12, 2028
February 17, 2026
February 1, 2026
3.7 years
February 4, 2026
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.
At baseline
Secondary Outcomes (2)
Evaluation of the possible use of the IT-TCP platform on the clinical level
At baseline
Creation of an IT platform to store and manage the data generated
At baseline
Study Arms (1)
Haematological neoplasms or neoplasms of solid organs
OTHER* 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.
Interventions
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.
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).
Individual biopsy samples will be evaluated in a pipeline that includes established diagnostic elements, e.g., cytogenetics and FISH.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients younger than 1 year old
- Patients with active, uncontrolled infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AO Riuniti Villa Sofia-Cervello di Palermo
Palermo, Palermo, 90146, Italy
University of Perugia
Perugia, Perugia, 06123, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 11, 2026
Study Start
May 31, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 12, 2028
Last Updated
February 17, 2026
Record last verified: 2026-02