Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-03-16 @ 8:10 AM
Study NCT ID:
NCT05918666
Status:
RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Register of Actionable Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of actionable mutations identified with NGS', 'timeFrame': 'from October 2018 to study completion, 2 years after the last enrolled patient', 'description': "information on somatic mutations obtained by analysis of neoplastic tissue samples and/or liquid biopsy (circulating tumor DNA extracted from the patient's plasma)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumours in Advanced Stages']}, 'referencesModule': {'references': [{'pmid': '26777916', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25087573', 'type': 'BACKGROUND', 'citation': 'Burrell RA, Swanton C. Tumour heterogeneity and the evolution of polyclonal drug resistance. Mol Oncol. 2014 Sep 12;8(6):1095-111. doi: 10.1016/j.molonc.2014.06.005. Epub 2014 Jul 10.'}, {'pmid': '31373836', 'type': 'BACKGROUND', 'citation': 'Davis W, Makar G, Mehta P, Zhu GG, Somer R, Morrison J, Kubicek GJ. Next-Generation Sequencing in 305 Consecutive Patients: Clinical Outcomes and Management Changes. J Oncol Pract. 2019 Dec;15(12):e1028-e1034. doi: 10.1200/JOP.19.00269. Epub 2019 Aug 2.'}, {'pmid': '23589557', 'type': 'BACKGROUND', 'citation': 'Garraway LA. Genomics-driven oncology: framework for an emerging paradigm. J Clin Oncol. 2013 May 20;31(15):1806-14. doi: 10.1200/JCO.2012.46.8934. Epub 2013 Apr 15.'}, {'pmid': '24846037', 'type': 'BACKGROUND', 'citation': 'Kris MG, Johnson BE, Berry LD, Kwiatkowski DJ, Iafrate AJ, Wistuba II, Varella-Garcia M, Franklin WA, Aronson SL, Su PF, Shyr Y, Camidge DR, Sequist LV, Glisson BS, Khuri FR, Garon EB, Pao W, Rudin C, Schiller J, Haura EB, Socinski M, Shirai K, Chen H, Giaccone G, Ladanyi M, Kugler K, Minna JD, Bunn PA. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014 May 21;311(19):1998-2006. doi: 10.1001/jama.2014.3741.'}, {'pmid': '25667274', 'type': 'BACKGROUND', 'citation': 'Lopez-Chavez A, Thomas A, Rajan A, Raffeld M, Morrow B, Kelly R, Carter CA, Guha U, Killian K, Lau CC, Abdullaev Z, Xi L, Pack S, Meltzer PS, Corless CL, Sandler A, Beadling C, Warrick A, Liewehr DJ, Steinberg SM, Berman A, Doyle A, Szabo E, Wang Y, Giaccone G. Molecular profiling and targeted therapy for advanced thoracic malignancies: a biomarker-derived, multiarm, multihistology phase II basket trial. J Clin Oncol. 2015 Mar 20;33(9):1000-7. doi: 10.1200/JCO.2014.58.2007. Epub 2015 Feb 9.'}, {'pmid': '26014291', 'type': 'BACKGROUND', 'citation': 'Meric-Bernstam F, Brusco L, Shaw K, Horombe C, Kopetz S, Davies MA, Routbort M, Piha-Paul SA, Janku F, Ueno N, Hong D, De Groot J, Ravi V, Li Y, Luthra R, Patel K, Broaddus R, Mendelsohn J, Mills GB. Feasibility of Large-Scale Genomic Testing to Facilitate Enrollment Onto Genomically Matched Clinical Trials. J Clin Oncol. 2015 Sep 1;33(25):2753-62. doi: 10.1200/JCO.2014.60.4165. Epub 2015 May 26.'}, {'pmid': '22991232', 'type': 'BACKGROUND', 'citation': 'Normanno N, Rachiglio AM, Roma C, Fenizia F, Esposito C, Pasquale R, La Porta ML, Iannaccone A, Micheli F, Santangelo M, Bergantino F, Costantini S, De Luca A. Molecular diagnostics and personalized medicine in oncology: challenges and opportunities. J Cell Biochem. 2013 Mar;114(3):514-24. doi: 10.1002/jcb.24401.'}, {'pmid': '32135080', 'type': 'BACKGROUND', 'citation': 'Pishvaian MJ, Blais EM, Brody JR, Lyons E, DeArbeloa P, Hendifar A, Mikhail S, Chung V, Sahai V, Sohal DPS, Bellakbira S, Thach D, Rahib L, Madhavan S, Matrisian LM, Petricoin EF 3rd. Overall survival in patients with pancreatic cancer receiving matched therapies following molecular profiling: a retrospective analysis of the Know Your Tumor registry trial. Lancet Oncol. 2020 Apr;21(4):508-518. doi: 10.1016/S1470-2045(20)30074-7. Epub 2020 Mar 2.'}, {'pmid': '31924700', 'type': 'BACKGROUND', 'citation': 'Smyth LM, Zhou Q, Nguyen B, Yu C, Lepisto EM, Arnedos M, Hasset MJ, Lenoue-Newton ML, Blauvelt N, Dogan S, Micheel CM, Wathoo C, Horlings H, Hudecek J, Gross BE, Kundra R, Sweeney SM, Gao J, Schultz N, Zarski A, Gardos SM, Lee J, Sheffler-Collins S, Park BH, Sawyers CL, Andre F, Levy M, Meric-Bernstam F, Bedard PL, Iasonos A, Schrag D, Hyman DM; AACR Project GENIE Consortium. Characteristics and Outcome of AKT1 E17K-Mutant Breast Cancer Defined through AACR Project GENIE, a Clinicogenomic Registry. Cancer Discov. 2020 Apr;10(4):526-535. doi: 10.1158/2159-8290.CD-19-1209. Epub 2020 Jan 10.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.', 'detailedDescription': '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.\n\nThe secondary objectives are:\n\n1. 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);\n2. describe, where possible, any variation in the molecular profile for patients who are subjected to genetic screening analysis at different stages of the disease.\n3. record retrospectively clinical efficacy and toxicity data when patients were treated with a target therapy based on the detected molecular alterations.\n\nThe national register of actionable mutations will be created collecting the following data:\n\n1. 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.\n2. 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.\n3. 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.\n\nOnly samples already available for clinical practice will be used in the study.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with solid tumors in advanced stage of disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'General Inclusion Criteria for all patients:\n\n* Age \\>18 years old\n* Life expectancy 6 months\n* ECOG performance status 2\n* Diagnosis of malignant solid tumor, in advanced stage\n* Informed consent to data registration and for privacy purposes\n\nAdditional inclusion criteria for patients that have already carried out a genetic characterisation extended by high throughput methods:\n\n● Availability of the result of the broad spectrum analysis of genetic alterations carried out with high throughput methods on biological samples\n\nAdditional inclusion criteria for patients that perform the molecular-genetic screening using Foundation Medicine services or in selected italian laboratories:\n\n* one of the following criteria:\n\n * Patients diagnosed with NSCLC not squamous, not pretreated;\n * Patients with biliary tract, pancreatic, esophagus, stomach, thymus, CNS, nasopharynx, salivary glands, endometrium and urothelium cancers;\n * 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;\n * Patients with cancer of unknown primary (CUP);\n * 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.\n* availability of biological material for testing.\n* informed consent for testing.\n\nAdditional exclusion criteria for patients that perform the molecular-genetic screening using Foundation Medicine services or in selected italian laboratories:\n\n● patients who have already received NGS or other high throughput in the same stage of disease.'}, 'identificationModule': {'nctId': 'NCT05918666', 'acronym': 'RATIONAL', 'briefTitle': 'National Register of Actionable Mutations', 'organization': {'class': 'OTHER', 'fullName': 'Federation of Italian Cooperative Oncology Groups'}, 'officialTitle': 'National Register of Actionable Mutations - Rational Study', 'orgStudyIdInfo': {'id': 'Rational study'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rossana Berardi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.O.D. Clinica Oncologica - A.O.U. Ospedali Riuniti Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Arezzo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alketa Hamzaj', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia Medica - Ospedale San Donato', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'city': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cesare Gridelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica - A.O. S.G. Moscati', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Aviano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Spina', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Divisione di Oncologia Medica e dei Tumori Immunocorrelati - Centro di Riferimento Oncologico', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Galetta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia Medica e Sperimentale - Istituto Tumori Giovanni Paolo II IRCCS', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giordano Beretta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica - Humanitas Gavazzeni', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Tondini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unità di Struttura Complessa Oncologia Medica - ASST Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Brindisi', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Saverio Cinieri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncologia Medica e Brest Unt - Presidio di Brindisi Di Summa-Perrino', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Hector Soto Parra', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia Medica - A.O.U. Policlinico Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Bordonaro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia Medica - Ospedale Garibaldi Nesima', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Antonuzzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C. di Oncologia Medica - A.O.U. Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Bennicelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.S. Tumori polmonari IRCCS A.O.U. San Martino IST - Istituto Nazionale per la Ricerca sul Cancro', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Meldola', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni L Frassineti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori S.r.l. IRCCS', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Adamo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica - A.O. Papardo', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giancarlo Pruneri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Siena', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Niguarda Cancer Center - Ospedale Niguarda e Università degli Studi di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Filippo De Marinis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncologia Toracica - Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Curigliano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sviluppo di nuovi Farmaci per Terapie Innovative - Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Normanno', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fortunato Ciardiello', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncologia Medica - A.O.U. Seconda Università degli studi di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Montesarchio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia - AORN - Ospedali dei Colli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Attademo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia - Asl Napoli 1 Centro - Ospedale del Mare', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Negrar', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefania Gori', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncologia - Ospedale Sacro Cuore Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Guarneri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica 2 - Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Russo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncologia Medica - A.O.U. Policlinico Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Pedrazzoli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C. Oncologia - Fondazione IRCCS Policlinico S. Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Minotti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C. Oncologia Medica - A.O. S.M. della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Cremolini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica 2 - Stabilimenteo S. Chiara - A.O.U. Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Reggio Emilia', 'status': 'SUSPENDED', 'country': 'Italy', 'facility': 'S.C. Oncologia - IRCCS Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Santini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Day Hospital - Oncologia Medica - Università Campus Biomedico di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Garufi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia - A.O. San Camillo -Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Mazzuca', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "U.O.C. Oncologia - A.O. Sant'Andrea", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria R Migliorino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.S.D. Pneumologia Oncologica - San Camillo Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Pepe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "U.O.C. Oncologia - A.O.U. OO.RR. San Giovanni di Dio Ruggi d'Aragona", 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'city': 'San Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Evaristo Maiello', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C. Oncologia - Fondazione Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Novello', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dipartimento di Oncologia - A.O.U. San Luigi Gonzaga', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucio Buffoni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C. Oncologia - Ospedale Humanitas Gradenigo', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Orazio Caffo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Oncologia Medica - Ospedale Santa Chiara', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'city': 'Treviglio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fausto Peterelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Oncologia - ASST Bergamo ovest', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'city': 'Treviso', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Aldo Favaretto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncologia Medica - Azienda ULSS 9', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianpiero Fasola', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dipartimento ad attività integrata di Oncologia - Azienda Sanitaria Universitaria Integrata di Udine Friuli Centrale', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Milella', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. di Oncologia medica - A.O.U. Integrata Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Nicola Normanno, MD', 'role': 'CONTACT', 'email': 'n.normanno@istitutotumori.na.it', 'phone': '081.5903111'}], 'overallOfficials': [{'name': 'Nicola Normanno', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INT- IRCCS Fondazione Pascale, Napoli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federation of Italian Cooperative Oncology Groups', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Janssen, LP', 'class': 'INDUSTRY'}, {'name': 'Takeda', 'class': 'INDUSTRY'}, {'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Clinical Research Technology S.r.l.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}