National Register of Actionable Mutations

NCT ID: NCT05918666

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2098 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-27
• Study Completion Date: 2026-10-27

Brief 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.

Conditions

Solid Tumours in Advanced Stages

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

● Availability of the result of the broad spectrum analysis of genetic alterations carried out with high throughput methods on biological samples

• 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.

Exclusion Criteria

● patients who have already received NGS or other high throughput in the same stage of disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Clinical Research Technology S.r.l.

INDUSTRY

Sponsor Role: collaborator

Federation of Italian Cooperative Oncology Groups

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Normanno

Role: STUDY_CHAIR

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori S.r.l. IRCCS

Locations

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

Napoli, , Italy

Oncologia Medica - A.O.U. Seconda Università degli studi di Napoli

Napoli, , Italy

U.O.C. Oncologia - AORN - Ospedali dei Colli

Napoli, , Italy

U.O.C. Oncologia - Asl Napoli 1 Centro - Ospedale del Mare

Napoli, , Italy

Oncologia - Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

U.O. Oncologia Medica 2 - Istituto Oncologico Veneto

Padua, , 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

UOC Oncologia Medica - ULSS 2 Marca Trevigiana - P.O. Treviso

Treviso, , Italy

Dipartimento ad attività integrata di Oncologia - Azienda Sanitaria Universitaria Integrata di Udine Friuli Centrale

Udine, , Italy

U.O.C. di Oncologia medica - A.O.U. Integrata Verona

Verona, , Italy

Countries

Italy

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Other Identifiers

Rational study

Identifier Type: -

Identifier Source: org_study_id