Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs.
Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test | Genetic | In order to proceed with molecular characterization, the tumor sample already taken for histological diagnosis will undergo DNA and RNA extraction, which will be analyzed for qualitative and quantitative evaluation. Based on the quantitative data, the method to be used for profiling will be decided. Multigenic genomic profiling will be performed for each patient on already taken tumor tissue using different panels depending on the quality and quantity of nucleic acids, in particular the following will be used: comprehensive Genome Profiling (CGP, ≥500 genes), if at least 40 ng of material is available; Profiling with identification of actionable mutations by targeted sequencing with panels of size >50 genes, if <40 ng material available. |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Genome Profiling | Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre | 5 years |
Not provided
Not provided
- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Scambia | Contact | 0630158668 | giovanni.scambia@policlinicogemelli.it | |
| Camilla Nero | Contact | 0630158668 | camilla.nero@policlinicogemelli.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40907210 | Derived | Mastrantoni L, Camarda F, Parrillo C, Persiani F, Trozzi R, Pasciuto T, Manfredelli M, Minucci A, De Paolis E, Capasso I, Iacobelli V, Perri MT, Zannoni GF, Fanfani F, Scambia G, Nero C. Gene actionability according to the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) in No Specific Molecular Profile (NSMP) endometrial cancer. ESMO Open. 2025 Sep;10(9):105755. doi: 10.1016/j.esmoop.2025.105755. Epub 2025 Sep 3. | |
| 40885102 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D042822 | Genomic Instability |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Derived |
| Vita E, Scala A, Vitale A, Mastrantoni L, Evangelista J, D'Auria F, Stefani A, Monaca F, Russo J, Horn G, Troisi P, Cosmai A, Polidori S, Di Salvatore M, De Paolis E, Minucci A, Nero C, Trisolini R, Cancellieri A, Scambia G, Tortora G, Bria E. Network analysis of NRG1 variants of uncertain significance (VUSes) in advanced non-small-cell lung cancer and their prognostic role in EGFR-mutant patients treated with first-line osimertinib. ESMO Open. 2025 Sep;10(9):105556. doi: 10.1016/j.esmoop.2025.105556. Epub 2025 Aug 29. |
| 39374480 | Derived | Vitale A, Mastrantoni L, Russo J, Giacomini F, Giannarelli D, Duranti S, Vita E, Nero C, D'Argento E, Pasciuto T, Giaco L, Di Salvatore M, Panfili A, Stefani A, Cancellieri A, Lococo F, De Paolis E, Livi V, Daniele G, Trisolini R, Minucci A, Margaritora S, Lorusso D, Normanno N, Scambia G, Tortora G, Bria E. Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary Results From the Lung Cancer Cohort of the FPG500 Program. JCO Precis Oncol. 2024 Oct;8:e2400297. doi: 10.1200/PO.24.00297. Epub 2024 Oct 7. |