National Register of Actionable Mutations

NCT05918666 | Active Not Recruiting

• 1 other identifier: Rational study
• Study Type: observational
• Target: 2,098
• Locations: 1 country
• Sites: 43

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.

Conditions

Solid Tumours in Advanced Stages

Outcome Measures

Primary Outcomes (1)

• rate of actionable mutations identified with NGS

  information on somatic mutations obtained by analysis of neoplastic tissue samples and/or liquid biopsy (circulating tumor DNA extracted from the patient's plasma).

  from October 2018 to study completion, 2 years after the last enrolled patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with solid tumors in advanced stage of disease

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (43)

S.O.D. Clinica Oncologica - A.O.U. Ospedali Riuniti Ancona

Ancona, Italy

Location

U.O.C. Oncologia Medica - Ospedale San Donato

Arezzo, Italy

Location

U.O. Oncologia Medica - A.O. S.G. Moscati

Avellino, Italy

Location

Divisione di Oncologia Medica e dei Tumori Immunocorrelati - Centro di Riferimento Oncologico

Aviano, Italy

Location

U.O.C. Oncologia Medica e Sperimentale - Istituto Tumori Giovanni Paolo II IRCCS

Bari, Italy

Location

U.O. Oncologia Medica - Humanitas Gavazzeni

Bergamo, Italy

Location

Unità di Struttura Complessa Oncologia Medica - ASST Papa Giovanni XXIII

Bergamo, Italy

Location

Oncologia Medica e Brest Unt - Presidio di Brindisi Di Summa-Perrino

Brindisi, Italy

Location

U.O.C. Oncologia Medica - A.O.U. Policlinico Vittorio Emanuele

Catania, Italy

Location

U.O.C. Oncologia Medica - Ospedale Garibaldi Nesima

Catania, Italy

Location

S.C. di Oncologia Medica - A.O.U. Careggi

Florence, Italy

Location

U.O.S. Tumori polmonari IRCCS A.O.U. San Martino IST - Istituto Nazionale per la Ricerca sul Cancro

Genova, Italy

Location

U.O. Oncologia Medica - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori S.r.l. IRCCS

Meldola, Italy

Location

Oncologia - AOU Policlinico "G. Martino"

Messina, Italy

Location

U.O. Oncologia Medica - A.O. Papardo

Messina, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Niguarda Cancer Center - Ospedale Niguarda e Università degli Studi di Milano

Milan, Italy

Location

Oncologia Toracica - Istituto Europeo di Oncologia

Milan, Italy

Location

Sviluppo di nuovi Farmaci per Terapie Innovative - Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale

Naples, Italy

Location

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

Naples, Italy

Location

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

Naples, Italy

Location

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

Naples, Italy

Location

Oncologia - Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Location

U.O. Oncologia Medica 2 - Istituto Oncologico Veneto

Padua, Italy

Location

Oncologia Medica - A.O.U. Policlinico Paolo Giaccone

Palermo, Italy

Location

S.C. Oncologia - Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

S.C. Oncologia Medica - A.O. S.M. della Misericordia

Perugia, Italy

Location

U.O. Oncologia Medica 2 - Stabilimenteo S. Chiara - A.O.U. Pisana

Pisa, Italy

Location

S.C. Oncologia - IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Location

Day Hospital - Oncologia Medica - Università Campus Biomedico di Roma

Roma, Italy

Location

U.O.C. Oncologia - A.O. San Camillo -Forlanini

Roma, Italy

Location

U.O.C. Oncologia - A.O. Sant'Andrea

Roma, Italy

Location

U.O.S.D. Pneumologia Oncologica - San Camillo Forlanini

Roma, Italy

Location

U.O.C. Oncologia - A.O.U. OO.RR. San Giovanni di Dio Ruggi d'Aragona

Salerno, Italy

Location

S.C. Oncologia - Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Dipartimento di Oncologia - A.O.U. San Luigi Gonzaga

Torino, Italy

Location

S.C. Oncologia - Ospedale Humanitas Gradenigo

Torino, Italy

Location

U.O. Oncologia Medica - Ospedale Santa Chiara

Trento, Italy

Location

U.O.C. Oncologia - ASST Bergamo ovest

Treviglio, Italy

Location

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

Treviso, Italy

Location

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

Udine, Italy

Location

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

Verona, Italy

Location

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• Barlesi F, Mazieres J, Merlio JP, Debieuvre D, Mosser J, Lena H, Ouafik L, Besse B, Rouquette I, Westeel V, Escande F, Monnet I, Lemoine A, Veillon R, Blons H, Audigier-Valette C, Bringuier PP, Lamy R, Beau-Faller M, Pujol JL, Sabourin JC, Penault-Llorca F, Denis MG, Lantuejoul S, Morin F, Tran Q, Missy P, Langlais A, Milleron B, Cadranel J, Soria JC, Zalcman G; Biomarkers France contributors. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016 Apr 2;387(10026):1415-1426. doi: 10.1016/S0140-6736(16)00004-0. Epub 2016 Jan 15.

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Study Officials

• Nicola Normanno

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 26, 2023
• Study Start: October 27, 2018
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 27, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-12

Locations

IT (43)