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NCT Number: NCT07403630

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

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.

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Key information

Conditions

Acute Leukemia Adenoma Adnexal Diseases Bladder Cancer Blood Protein Disorders Bone Marrow Diseases Carcinoma Carcinoma, Squamous Cell Cardiovascular Diseases Chronic Leukemia Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Mesothelioma Mesothelioma, Malignant Multiple Myeloma Myelodysplastic Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pediatric Acute Lymphoblastic Leukemia Pleural Mesothelioma Pleural Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AO Riuniti Villa Sofia-Cervello di Palermo, Palermo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional tests

Biological

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

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Roti, Associate Professor

CONTACT

[email protected]

+39 0521 702200

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Acronym: IT-TCP POS

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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