Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-02-25 @ 5:42 PM
Study NCT ID:
NCT03347318
Status:
UNKNOWN
Last Update Posted:
2017-11-20
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, saliva, feces, urine and tumor specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patient correctly sampled', 'timeFrame': 'through study completion, an average of five years', 'description': 'number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients.'}], 'secondaryOutcomes': [{'measure': 'number of patients with detected genetic alterations that respond to treatments assigned by physician.', 'timeFrame': 'through study completion, an average of five years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to define the molecular profile of selected solid tumors. From each participants will be collected biological materials for molecular analysis, including saliva, blood and vital tumor tissue derived form surgical or biopsy procedures. Whereas possible, vital tumor specimens will be inoculated and propagated in immunocompromised NOD/SCID mice to study the genetic correlations between genetic status and response to target drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with selected solid tumors (CRC, Prostate Cancer, Head \\& Neck Cancer, Gastric Cancer, Glioblastoma, Breast Cancer, Hepatocarcinoma, Biliary Tract Carcinoma, Lung Cancer, Rare Tumors, Metastatic Sarcoma and Metastatic Melanoma).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with at least one of the following selected solid tumors:\n\n* Colorectal Cancer (primary or with synchronous/metachronous liver metastases)\n* Prostate Cancer\n* Head \\& Neck Tumors\n* Gastric Cancer\n* Glioblastoma\n* Breast Cancer\n* Hepatocarcinoma\n* Biliary Tract Carcinoma\n* Lung Cancer (primary)\n* Rare Tumors (incidence ≤ 5x10-6)\n* Metastatic Sarcoma\n* Metastatic Melanoma\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03347318', 'acronym': 'PROFILING', 'briefTitle': 'Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'Non-interventional Study for the Determination of Molecular Resistance Profiling to Targeted Therapies in Patients With Neoplastic Disease', 'orgStudyIdInfo': {'id': '001-IRCC-00IIS-10'}}, 'contactsLocationsModule': {'locations': [{'city': 'Aosta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Trogu, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Regionale Umberto Parini', 'geoPoint': {'lat': 45.73764, 'lon': 7.31722}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Ardizzoni, MD', 'role': 'CONTACT'}], 'facility': 'Policlinico S.Orsola Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Candiolo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Marsoni, MD', 'role': 'CONTACT'}], 'facility': "Istituto Di Candiolo - Fondazione Del Piemonte Per L'Oncologia (FPO-Irccs)", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico Mini, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria Careggi', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Siena, MD', 'role': 'CONTACT'}], 'facility': "Azienda Ospedaliera Niguarda Ca'Granda", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Curigliano, MD', 'role': 'CONTACT'}], 'facility': 'IEO - Istiuto Europeo di Oncologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Filippo De Braud, MD', 'role': 'CONTACT'}], 'facility': 'Fondazione IRCCS - Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Orbassano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Novello, MD', 'role': 'CONTACT'}], 'facility': 'AOU S. Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vittorina Zagonel, MD', 'role': 'CONTACT', 'email': 'vittorina.zagonel@iov.veneto.it'}], 'facility': 'IOV - Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alfredo Falcone, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Tonini, MD', 'role': 'CONTACT', 'email': 'g.tonini@unicampus.it'}], 'facility': 'Policlinico Universitario Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Gregori, MD', 'role': 'CONTACT'}], 'facility': "A.O. Città della Salute e della Scienza di Torino - Presidio ospedaliero Ostetrico Ginecologico Sant'Anna", 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Cassoni, MD', 'role': 'CONTACT'}], 'facility': 'AOU Città della Salute e della Scienza di Torino - Presidio Molinette', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Ferrero, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Mauriziano Umberto I', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Erika Crosetti, MD', 'role': 'CONTACT'}], 'facility': 'Presidio Ospedaliero Martini', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'centralContacts': [{'name': 'Silvia Marsoni, MD', 'role': 'CONTACT', 'email': 'silvia.marsoni@ircc.it'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}