Clinical trial Recruiting at 2 sites Interventional Ages 1 Year and up

Comprehensive multi-omics and functional profiling to fully characterize tumors

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

Run by Azienda Ospedaliero-Universitaria di Parma · NCT07403630 · Data updated 2026-11-12

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

Study typeInterventional
Ages1 Year and up
SexAll
Enrollment300 (estimated)
SponsorAzienda Ospedaliero-Universitaria di Parma
Academic / other
Locations2 sites (Palermo, Palermo and 1 other locations)
StatusRecruiting
StartedMay 31, 2023
Main results expectedFebruary 2027
Study endsFebruary 12, 2028
Registry record updatedFebruary 17, 2026
Trial IDNCT07403630 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • AO Riuniti Villa Sofia-Cervello di Palermo
    Palermo, Palermo, Italy
    Recruiting
  • University of Perugia
    Perugia, Perugia, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.