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RATIONAL: National Register of Actionable Mutations

Sponsor
Federation of Italian Cooperative Oncology Groups (Other)
Overall Status
Recruiting
CT.gov ID
NCT05918666
Collaborator
Roche Pharma AG (Industry), AstraZeneca (Industry), Bayer (Industry), Bristol-Myers Squibb (Industry), Janssen, LP (Industry), Takeda (Industry), Amgen (Industry), Daiichi Sankyo, Inc. (Industry), Eli Lilly and Company (Industry), Novartis (Industry), Clinical Research Technology S.r.l. (Industry)
3,000
Enrollment
42
Locations
96
Anticipated Duration (Months)
71.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    National Register of Actionable Mutations - Rational Study
    Actual Study Start Date :
    Oct 27, 2018
    Anticipated Primary Completion Date :
    Oct 27, 2026
    Anticipated Study Completion Date :
    Oct 27, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 S.O.D. Clinica Oncologica - A.O.U. Ospedali Riuniti Ancona Ancona Italy
    2 U.O.C. Oncologia Medica - Ospedale San Donato Arezzo Italy
    3 U.O. Oncologia Medica - A.O. S.G. Moscati Avellino Italy
    4 Divisione di Oncologia Medica e dei Tumori Immunocorrelati - Centro di Riferimento Oncologico Aviano Italy
    5 U.O.C. Oncologia Medica e Sperimentale - Istituto Tumori Giovanni Paolo II IRCCS Bari Italy
    6 U.O. Oncologia Medica - Humanitas Gavazzeni Bergamo Italy
    7 Unità di Struttura Complessa Oncologia Medica - ASST Papa Giovanni XXIII Bergamo Italy
    8 Oncologia Medica e Brest Unt - Presidio di Brindisi Di Summa-Perrino Brindisi Italy
    9 U.O.C. Oncologia Medica - A.O.U. Policlinico Vittorio Emanuele Catania Italy
    10 U.O.C. Oncologia Medica - Ospedale Garibaldi Nesima Catania Italy
    11 S.C. di Oncologia Medica - A.O.U. Careggi Firenze Italy
    12 U.O.S. Tumori polmonari IRCCS A.O.U. San Martino IST - Istituto Nazionale per la Ricerca sul Cancro Genova Italy
    13 U.O. Oncologia Medica - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori S.r.l. IRCCS Meldola Italy
    14 U.O. Oncologia Medica - A.O. Papardo Messina Italy
    15 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy
    16 Niguarda Cancer Center - Ospedale Niguarda e Università degli Studi di Milano Milano Italy
    17 Oncologia Toracica - Istituto Europeo di Oncologia Milano Italy
    18 Sviluppo di nuovi Farmaci per Terapie Innovative - Istituto Europeo di Oncologia Milano Italy
    19 Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale Napoli Italy
    20 Oncologia Medica - A.O.U. Seconda Università degli studi di Napoli Napoli Italy
    21 U.O.C. Oncologia - AORN - Ospedali dei Colli Napoli Italy
    22 U.O.C. Oncologia - Asl Napoli 1 Centro - Ospedale del Mare Napoli Italy
    23 Oncologia - Ospedale Sacro Cuore Don Calabria Negrar Italy
    24 U.O. Oncologia Medica 2 - Istituto Oncologico Veneto Padova Italy
    25 Oncologia Medica - A.O.U. Policlinico Paolo Giaccone Palermo Italy
    26 S.C. Oncologia - Fondazione IRCCS Policlinico S. Matteo Pavia Italy
    27 S.C. Oncologia Medica - A.O. S.M. della Misericordia Perugia Italy
    28 U.O. Oncologia Medica 2 - Stabilimenteo S. Chiara - A.O.U. Pisana Pisa Italy
    29 S.C. Oncologia - IRCCS Arcispedale Santa Maria Nuova Reggio Emilia Italy
    30 Day Hospital - Oncologia Medica - Università Campus Biomedico di Roma Roma Italy
    31 U.O.C. Oncologia - A.O. San Camillo -Forlanini Roma Italy
    32 U.O.C. Oncologia - A.O. Sant'Andrea Roma Italy
    33 U.O.S.D. Pneumologia Oncologica - San Camillo Forlanini Roma Italy
    34 U.O.C. Oncologia - A.O.U. OO.RR. San Giovanni di Dio Ruggi d'Aragona Salerno Italy
    35 S.C. Oncologia - Fondazione Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
    36 Dipartimento di Oncologia - A.O.U. San Luigi Gonzaga Torino Italy
    37 S.C. Oncologia - Ospedale Humanitas Gradenigo Torino Italy
    38 U.O. Oncologia Medica - Ospedale Santa Chiara Trento Italy
    39 U.O.C. Oncologia - ASST Bergamo ovest Treviglio Italy
    40 Oncologia Medica - Azienda ULSS 9 Treviso Italy
    41 Dipartimento ad attività integrata di Oncologia - Azienda Sanitaria Universitaria Integrata di Udine Friuli Centrale Udine Italy
    42 U.O.C. di Oncologia medica - A.O.U. Integrata Verona Verona Italy

    Sponsors and Collaborators

    • Federation of Italian Cooperative Oncology Groups
    • Roche Pharma AG
    • AstraZeneca
    • Bayer
    • Bristol-Myers Squibb
    • Janssen, LP
    • Takeda
    • Amgen
    • Daiichi Sankyo, Inc.
    • Eli Lilly and Company
    • Novartis
    • Clinical Research Technology S.r.l.

    Investigators

    • Principal Investigator: Nicola Normanno, INT- IRCCS Fondazione Pascale, Napoli

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Federation of Italian Cooperative Oncology Groups
    ClinicalTrials.gov Identifier:
    NCT05918666
    Other Study ID Numbers:
    • Rational study
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 26, 2023