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

ConditionsAcute LeukemiaMultiple MyelomaSquamous Cell CarcinomaPleural MesotheliomaPancreatic CancerBladder CancerOvarian CancerMelanomaPediatric Acute Lymphoblastic LeukemiaChronic LeukemiaMyeloproliferative DisordersMyelodysplastic Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorAzienda Ospedaliero-Universitaria di Parma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients younger than 1 year old

Patients with active, uncontrolled infections

Trial design

Design model

Single group

Treatments tested in this trial

  • Functional tests

    Biological/Vaccine

    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 analyses

    Other intervention

    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/ FISH

    Genetic

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Haematological neoplasms or neoplasms of solid organsOther 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
At baseline

Secondary outcomes

1

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

Time frame
At baseline
2

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

Time frame
At baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Parma

Lead sponsor

University of Parma

Sponsor institution

Source ClinicalTrials.gov
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