NCT07403630

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria di Parma · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Leukemia
• Multiple Myeloma
• Squamous Cell Carcinoma
• Pleural Mesothelioma
• Pancreatic Cancer
• Bladder Cancer
• Ovarian Cancer
• Melanoma
• Pediatric Acute Lymphoblastic Leukemia
• Chronic Leukemia
• Myeloproliferative Disorders
• Myelodysplastic Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-31
• Primary completion: 2027-02-01
• Completion: 2028-02-12
• First posted: 2026-02-11
• Last updated: 2026-02-17

Locations

2 sites across 1 country: Italy