Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-01 @ 5:52 AM
Study NCT ID:
NCT06076005
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2023-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of histologic subtypes', 'timeFrame': '24 months', 'description': 'The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer'}], 'secondaryOutcomes': [{'measure': 'Distribution of histologic subtypes according to clinical and radiological characteristics', 'timeFrame': '24 months', 'description': 'The investigators will assess the prevalence of different histologic subtypes according to clinical and imaging characteristics'}, {'measure': 'Molecular profiling', 'timeFrame': '24 months', 'description': 'Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology'}, {'measure': 'Time to diagnosis', 'timeFrame': '24 months', 'description': 'Time lag between onset of symptoms (if any) and invasive testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Suspicion of lung cancer based on imaging (CT and/or PET/CT)\n* Indication to a biopsy for diagnosis, staging and/or molecular profiling\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide a written informed consent\n* ECOG performance status (\\>3) which makes a tissue diagnosis unfeasible\n* ASA 4 status\n* TNM Stage I-III'}, 'identificationModule': {'nctId': 'NCT06076005', 'acronym': 'LUNG-CANCER', 'briefTitle': 'Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohor', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Demographic, Clinical, Histological and Molecular Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohort, an Observational Cohort Study: Lung Cancer ID Study', 'orgStudyIdInfo': {'id': '5937'}}, 'armsInterventionsModule': {'interventions': [{'name': "Advanced lung cancer patients' group", 'type': 'OTHER', 'description': 'Evaluation of the demographic, clinical, histological and molecular characteristics of advanced lung cancer at the time of Diagnosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marta Viscuso, MD', 'role': 'CONTACT', 'email': 'marta.viscuso@guest.policlinicogemelli.it'}], 'facility': 'Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Cappuzzo, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Nazionale Tumori Regina Elena', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emilio Bria', 'role': 'CONTACT'}], 'facility': 'Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Rocco Trisolini, MD', 'role': 'CONTACT', 'email': 'rocco.trisolini@policlinicogemelli.it', 'phone': '0630154163'}], 'overallOfficials': [{'name': 'Rocco Trisolini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators will decide how to share the data at the end of the study upon reasonable request to be addressed to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}