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

Azienda Ospedaliero-Universitaria di Parma300 enrolled

Overview

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.

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

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

300

Conditions

Acute Leukemia Multiple Myeloma Squamous Cell Carcinoma

Interventions

Functional testsBIOLOGICAL

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.

Multi-omics analysesOTHER

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).

Cytogenetics/ FISHGENETIC

Individual biopsy samples will be evaluated in a pipeline that includes established diagnostic elements, e.g., cytogenetics and FISH.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.

Time frame: At baseline

Secondary Outcomes

Evaluation of the possible use of the IT-TCP platform on the clinical level

Time frame: At baseline

Creation of an IT platform to store and manage the data generated

Time frame: At baseline

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts