Trial Title:
National Register of Actionable Mutations
NCT ID:
NCT05918666
Condition:
Solid Tumours in Advanced Stages
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Detailed description:
The primary objective of this observational study is to describe the frequency of
actionable mutations in patients with solid tumors in advanced stage, receiving a
genetic-molecular characterization with high throughput methods.
The secondary objectives are:
1. assess the correlation between genetic alterations and clinical and pathological
characteristics of enrolled patients (gender, age, histological variant, location
and extent of neoplasm, comorbidity, familiarity for neoplasms);
2. describe, where possible, any variation in the molecular profile for patients who
are subjected to genetic screening analysis at different stages of the disease.
3. record retrospectively clinical efficacy and toxicity data when patients were
treated with a target therapy based on the detected molecular alterations.
The national register of actionable mutations will be created collecting the following
data:
1. Data extracted retrospectively from medical records of patients that have received
during the study period a test with high-throughput technologies for the molecular
characterization of their tumor, either by clinical routine or for research
purposes.
2. Data collected prospectively from analysis of biological samples (FFPE and biopsy
liquid) of patients that meet the elibility criteria and that perform the
molecular-genetic screening using Foundation Medicine services or in selected
italian laboratories.
3. Clinical data collected retrospectively (RR, DOR, PFS, OS, toxicity), in case where
the patients are treated with a target therapy, based on the highlighted molecular
alterations and on the choice of the clinician.
Only samples already available for clinical practice will be used in the study.
The register will be limited to collecting information on molecular alterations that can
then be used for the insertion of patients in clinical studies already active, for the
design of new studies proposed by members of the Steering Committee or of the
participating sites, or for treatment with other modality.
Criteria for eligibility:
Study pop:
patients with solid tumors in advanced stage of disease
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
S.O.D. Clinica Oncologica - A.O.U. Ospedali Riuniti Ancona
Address:
City:
Ancona
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Rossana Berardi
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia Medica - Ospedale San Donato
Address:
City:
Arezzo
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Alketa Hamzaj
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica - A.O. S.G. Moscati
Address:
City:
Avellino
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Cesare Gridelli
Email:
Principal Investigator
Facility:
Name:
Divisione di Oncologia Medica e dei Tumori Immunocorrelati - Centro di Riferimento Oncologico
Address:
City:
Aviano
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Michele Spina
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia Medica e Sperimentale - Istituto Tumori Giovanni Paolo II IRCCS
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Domenico Galetta
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica - Humanitas Gavazzeni
Address:
City:
Bergamo
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Giordano Beretta
Email:
Principal Investigator
Facility:
Name:
Unità di Struttura Complessa Oncologia Medica - ASST Papa Giovanni XXIII
Address:
City:
Bergamo
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Carlo Tondini
Email:
Principal Investigator
Facility:
Name:
Oncologia Medica e Brest Unt - Presidio di Brindisi Di Summa-Perrino
Address:
City:
Brindisi
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Saverio Cinieri
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia Medica - A.O.U. Policlinico Vittorio Emanuele
Address:
City:
Catania
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Hector Soto Parra
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia Medica - Ospedale Garibaldi Nesima
Address:
City:
Catania
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Roberto Bordonaro
Email:
Principal Investigator
Facility:
Name:
S.C. di Oncologia Medica - A.O.U. Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Lorenzo Antonuzzo
Email:
Principal Investigator
Facility:
Name:
U.O.S. Tumori polmonari IRCCS A.O.U. San Martino IST - Istituto Nazionale per la Ricerca sul Cancro
Address:
City:
Genova
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Elisa Bennicelli
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori S.r.l. IRCCS
Address:
City:
Meldola
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Giovanni L Frassineti
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica - A.O. Papardo
Address:
City:
Messina
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Vincenzo Adamo
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Giancarlo Pruneri
Email:
Principal Investigator
Facility:
Name:
Niguarda Cancer Center - Ospedale Niguarda e Università degli Studi di Milano
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Salvatore Siena
Email:
Principal Investigator
Facility:
Name:
Oncologia Toracica - Istituto Europeo di Oncologia
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Filippo De Marinis
Email:
Principal Investigator
Facility:
Name:
Sviluppo di nuovi Farmaci per Terapie Innovative - Istituto Europeo di Oncologia
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Giuseppe Curigliano
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Nicola Normanno
Email:
Principal Investigator
Facility:
Name:
Oncologia Medica - A.O.U. Seconda Università degli studi di Napoli
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Fortunato Ciardiello
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia - AORN - Ospedali dei Colli
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Vincenzo Montesarchio
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia - Asl Napoli 1 Centro - Ospedale del Mare
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Laura Attademo
Email:
Principal Investigator
Facility:
Name:
Oncologia - Ospedale Sacro Cuore Don Calabria
Address:
City:
Negrar
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Stefania Gori
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica 2 - Istituto Oncologico Veneto
Address:
City:
Padova
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Valentina Guarneri
Email:
Principal Investigator
Facility:
Name:
Oncologia Medica - A.O.U. Policlinico Paolo Giaccone
Address:
City:
Palermo
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Antonio Russo
Email:
Principal Investigator
Facility:
Name:
S.C. Oncologia - Fondazione IRCCS Policlinico S. Matteo
Address:
City:
Pavia
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Paolo Pedrazzoli
Email:
Principal Investigator
Facility:
Name:
S.C. Oncologia Medica - A.O. S.M. della Misericordia
Address:
City:
Perugia
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Vincenzo Minotti
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica 2 - Stabilimenteo S. Chiara - A.O.U. Pisana
Address:
City:
Pisa
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Chiara Cremolini
Email:
Principal Investigator
Facility:
Name:
S.C. Oncologia - IRCCS Arcispedale Santa Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Suspended
Facility:
Name:
Day Hospital - Oncologia Medica - Università Campus Biomedico di Roma
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Daniele Santini
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia - A.O. San Camillo -Forlanini
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Carlo Garufi
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia - A.O. Sant'Andrea
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Federica Mazzuca
Email:
Principal Investigator
Facility:
Name:
U.O.S.D. Pneumologia Oncologica - San Camillo Forlanini
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Maria R Migliorino
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia - A.O.U. OO.RR. San Giovanni di Dio Ruggi d'Aragona
Address:
City:
Salerno
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Stefano Pepe
Email:
Principal Investigator
Facility:
Name:
S.C. Oncologia - Fondazione Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Evaristo Maiello
Email:
Principal Investigator
Facility:
Name:
Dipartimento di Oncologia - A.O.U. San Luigi Gonzaga
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Silvia Novello
Email:
Principal Investigator
Facility:
Name:
S.C. Oncologia - Ospedale Humanitas Gradenigo
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Lucio Buffoni
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica - Ospedale Santa Chiara
Address:
City:
Trento
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Orazio Caffo
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia - ASST Bergamo ovest
Address:
City:
Treviglio
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Fausto Peterelli
Email:
Principal Investigator
Facility:
Name:
Oncologia Medica - Azienda ULSS 9
Address:
City:
Treviso
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Aldo Favaretto
Email:
Principal Investigator
Facility:
Name:
Dipartimento ad attività integrata di Oncologia - Azienda Sanitaria Universitaria Integrata di Udine Friuli Centrale
Address:
City:
Udine
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Gianpiero Fasola
Email:
Principal Investigator
Facility:
Name:
U.O.C. di Oncologia medica - A.O.U. Integrata Verona
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Michele Milella
Email:
Principal Investigator
Start date:
October 27, 2018
Completion date:
October 27, 2026
Lead sponsor:
Agency:
Federation of Italian Cooperative Oncology Groups
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Bayer
Agency class:
Industry
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Janssen, LP
Agency class:
Industry
Collaborator:
Agency:
Takeda
Agency class:
Industry
Collaborator:
Agency:
Amgen
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
Eli Lilly and Company
Agency class:
Industry
Collaborator:
Agency:
Novartis
Agency class:
Industry
Collaborator:
Agency:
Clinical Research Technology S.r.l.
Agency class:
Industry
Source:
Federation of Italian Cooperative Oncology Groups
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918666
