Comprehensive multi-omics and functional profiling to fully characterize tumors
INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)
This project tests whether detailed multi-omics and functional testing of tumor samples can better characterize high-risk blood and solid cancers for patients at participating centers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma Academic / other |
| Locations | 2 sites (Palermo, Palermo and 1 other locations) |
| Trial ID | NCT07403630 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter preclinical program that collects primary tumor samples from consecutively enrolled patients with high-risk hematologic or solid malignancies. Samples undergo integrated multi-omics analyses (genomic, transcriptomic and other molecular profiling), cytogenetics/FISH, and ex vivo functional tests to map tumor features. The aim is to generate a complete diagnostic and chemogenomic profile that could help interpret disease biology and highlight actionable vulnerabilities. Enrollment occurs at participating Italian centers and includes patients with relapsed, refractory, metastatic, or otherwise high-risk disease.
Who should consider this trial
Good fit: Ideal candidates are patients aged one year and older with a confirmed high-risk hematologic or solid malignancy (including relapsed, refractory, or metastatic disease) who can provide tumor samples and consent at a participating center.
Not a fit: Patients with low-risk disease, insufficient or unavailable tumor material, or those who cannot attend the participating Italian centers are unlikely to gain benefit from this program.
Why it matters
Potential benefit: If successful, the platform could reveal molecular and functional tumor features that help doctors choose more personalized treatment options.
How similar studies have performed: Similar multi-omics and ex vivo functional profiling approaches have shown promise in early studies for identifying actionable targets, but they remain largely experimental and are not yet standard clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palermo, Palermo and 1 other locations
- AO Riuniti Villa Sofia-Cervello di Palermo — Palermo, Palermo, Italy (Recruiting)
- University of Perugia — Perugia, Perugia, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Roti, Associate Professor
- Email: giovanni.roti@unipr.it
- Phone: +39 0521 702200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.