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Active, not recruiting Observational

National Register of Actionable Mutations

NCT05918666 · tracked via the Priya Life Science Italy tracker
Sponsor
Federation of Italian Cooperative Oncology Groups
Phase
Observational
Started
2018-10-27
Last updated
2026-01-30

Condition(s) studied

Solid Tumours in Advanced Stages

Study summary

The goal of this observational study is the creation of a national network of precision medicine, which allows to increase, for Italian patients suffering from solid tumors, the possibility of access to more innovative therapies and to collect retrospectively their clinical data.

For this purpose, a national register of actionable mutations in patients with solid tumors in advanced stage of disease will be created in which various individual, local and regional initiatives of genomic screening of cancer could merge.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
General Inclusion Criteria for all patients: * Age \>18 years old * Life expectancy 6 months * ECOG performance status 2 * Diagnosis of malignant solid tumor, in advanced stage * Informed consent to data registration and for privacy purposes Additional inclusion criteria for patients that have already carried out a genetic characterisation extended by high throughput methods: ● Availability of the result of the broad spectrum analysis of genetic alterations carried out with high throughput methods on biological samples Additional inclusion criteria for patients that perform the molecular-genetic screening using Foundation Medicine services or in selected italian laboratories: * one of the following criteria: * Patients diagnosed with NSCLC not squamous, not pretreated; * Patients with biliary tract, pancreatic, esophagus, stomach, thymus, CNS, nasopharynx, salivary glands, endometrium and urothelium cancers; * Patients with any disease (including NSCLC) who are progressing disease after treatment with molecular target drugs. For these patients is the availability of a post- treatment biological sample is necessary; * Patients with cancer of unknown primary (CUP); * Young patients (\<40 years) or patients who have exhausted standard lines of therapy, with any advanced/metastatic tumor which, in the opinion of the investigator, may benefit from a genetic-molecular characterization at broad spectrum aimed at a treatment with molecular target therapies. * availability of biological material for testing. * informed consent for testing. Additional exclusion criteria for patients that perform the molecular-genetic screening using Foundation Medicine services or in selected italian laboratories: ● patients who have already received NGS or other high throughput in the same stage of disease.

Primary outcome measure(s)

  • rate of actionable mutations identified with NGS — from October 2018 to study completion, 2 years after the last enrolled patient
    information on somatic mutations obtained by analysis of neoplastic tissue samples and/or liquid biopsy (circulating tumor DNA extracted from the patient's plasma).

Trial sites (43)

FacilityCityRegionStatus
S.O.D. Clinica Oncologica - A.O.U. Ospedali Riuniti Ancona Ancona Italy
U.O.C. Oncologia Medica - Ospedale San Donato Arezzo Italy
U.O. Oncologia Medica - A.O. S.G. Moscati Avellino Italy
Divisione di Oncologia Medica e dei Tumori Immunocorrelati - Centro di Riferimento Oncologico Aviano Italy
U.O.C. Oncologia Medica e Sperimentale - Istituto Tumori Giovanni Paolo II IRCCS Bari Italy
U.O. Oncologia Medica - Humanitas Gavazzeni Bergamo Italy
Unità di Struttura Complessa Oncologia Medica - ASST Papa Giovanni XXIII Bergamo Italy
Oncologia Medica e Brest Unt - Presidio di Brindisi Di Summa-Perrino Brindisi Italy
U.O.C. Oncologia Medica - A.O.U. Policlinico Vittorio Emanuele Catania Italy
U.O.C. Oncologia Medica - Ospedale Garibaldi Nesima Catania Italy
S.C. di Oncologia Medica - A.O.U. Careggi Florence Italy
U.O.S. Tumori polmonari IRCCS A.O.U. San Martino IST - Istituto Nazionale per la Ricerca sul Cancro Genova Italy
U.O. Oncologia Medica - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori S.r.l. IRCCS Meldola Italy
Oncologia - AOU Policlinico "G. Martino" Messina Italy
U.O. Oncologia Medica - A.O. Papardo Messina Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
Niguarda Cancer Center - Ospedale Niguarda e Università degli Studi di Milano Milan Italy
Oncologia Toracica - Istituto Europeo di Oncologia Milan Italy
Sviluppo di nuovi Farmaci per Terapie Innovative - Istituto Europeo di Oncologia Milan Italy
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale Naples Italy
Oncologia Medica - A.O.U. Seconda Università degli studi di Napoli Naples Italy
U.O.C. Oncologia - AORN - Ospedali dei Colli Naples Italy
U.O.C. Oncologia - Asl Napoli 1 Centro - Ospedale del Mare Naples Italy
Oncologia - Ospedale Sacro Cuore Don Calabria Negrar Italy
U.O. Oncologia Medica 2 - Istituto Oncologico Veneto Padova Italy
Oncologia Medica - A.O.U. Policlinico Paolo Giaccone Palermo Italy
S.C. Oncologia - Fondazione IRCCS Policlinico S. Matteo Pavia Italy
S.C. Oncologia Medica - A.O. S.M. della Misericordia Perugia Italy
U.O. Oncologia Medica 2 - Stabilimenteo S. Chiara - A.O.U. Pisana Pisa Italy
S.C. Oncologia - IRCCS Arcispedale Santa Maria Nuova Reggio Emilia Italy
Day Hospital - Oncologia Medica - Università Campus Biomedico di Roma Roma Italy
U.O.C. Oncologia - A.O. San Camillo -Forlanini Roma Italy
U.O.C. Oncologia - A.O. Sant'Andrea Roma Italy
U.O.S.D. Pneumologia Oncologica - San Camillo Forlanini Roma Italy
U.O.C. Oncologia - A.O.U. OO.RR. San Giovanni di Dio Ruggi d'Aragona Salerno Italy
S.C. Oncologia - Fondazione Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
Dipartimento di Oncologia - A.O.U. San Luigi Gonzaga Torino Italy
S.C. Oncologia - Ospedale Humanitas Gradenigo Torino Italy
U.O. Oncologia Medica - Ospedale Santa Chiara Trento Italy
U.O.C. Oncologia - ASST Bergamo ovest Treviglio Italy

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05918666 on ClinicalTrials.gov ↗ ← All trials in Italy