Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
Study NCT ID:
NCT04227457
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2018-01-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival of advanced NSCLC in Latin America', 'timeFrame': 'Annually, during 3 years', 'description': 'Time from randomization or initiation of treatment to patient death'}], 'secondaryOutcomes': [{'measure': 'Description of socioeconomic characteristics of patients newly diagnosed with advanced NSCLC', 'timeFrame': 'Annually, during 3 years', 'description': 'Description of the socioeconomical characteristics of the Latin America population with newly advanced NSCLC'}, {'measure': 'Description of pathological profile of advanced NSCLC', 'timeFrame': 'Annually, during 3 years', 'description': 'Analysis of histology and molecular markers of advanced NSCLC'}, {'measure': 'Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC', 'timeFrame': 'Annually, during 3 years', 'description': 'Description of the practice patterns of therapeutic agents for treatment of advanced NSCLC'}, {'measure': 'Description of the treatment responses', 'timeFrame': 'Annually, during 3 years', 'description': 'Description of the treatment responses'}, {'measure': 'Description of Treatment discontinuation', 'timeFrame': 'Annually, during 3 years', 'description': 'Description of the reasons for treatment discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To describe the overall survival of advanced NSCLC in Latin America.', 'detailedDescription': '* To describe demographic and socioeconomic characteristics of patients newly diagnosed with advanced NSCLC\n* To describe diagnostic methods, pathological profile and disease stage at diagnosis of advanced NSCLC\n* To describe the practice patterns of therapeutic agents for treatment of advanced NSCLC\n* To describe treatment responses, progression and survival times.\n* To describe reasons for treatment discontinuation\n* To identify associations between patient demographics, socioeconomic, pathology, treatment sequences and overall survival;\n* To define the patient experience of advanced NSCLC and identify unmet needs in their diagnose and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The LATINO Lung study will prospectively recruit a minimum of 700 and up to 800 patients with advanced NSCLC, including locally advanced disease not amenable to curative treatment or metastatic disease from sites in Argentina, Brazil, Chile, Colombia, and Mexico. Other countries may be invited to participate.\n\nPatients will be recruited during an initial study period of 3 months, or more to reach the study minimum sample size, and will be followed for 3 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 years or older;\n2. Newly diagnosed Non-Small Cell Lung Cancer (NSCLC) during the period of the study (which includes 3 months prior to site activation by LACOG, although they can have received anti-cancer treatment during that time);\n3. Histologically or cytologically confirmed advanced NSCLC:\n\n 1. Stage IIIB that progressed after curative therapy (chemoradiation and/or surgery);\n 2. Stage IV metastatic disease (de novo or distant relapse)\n4. Any NSCLC histological subtype and molecular mutation;\n5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;\n6. Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy) or palliative care;\n7. Access to patient medical chart for data collection;\n8. Willing and able to provide written informed consent and privacy authorization for the release of personal health information.'}, 'identificationModule': {'nctId': 'NCT04227457', 'acronym': 'LATINO Lung', 'briefTitle': 'Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America', 'organization': {'class': 'OTHER', 'fullName': 'Latin American Cooperative Oncology Group'}, 'officialTitle': 'Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America', 'orgStudyIdInfo': {'id': 'LACOG 0116'}}, 'contactsLocationsModule': {'locations': [{'city': 'La Rioja', 'state': 'Rioja', 'country': 'Argentina', 'facility': 'Centro Oncologico Riojano', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'city': 'Santa Fe', 'state': 'Rosário', 'country': 'Argentina', 'facility': 'Instituto De Oncologia De Rosario', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'city': 'Córdoba', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro Medico San Roque'}, {'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'CRIO', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'CLION', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'NOB', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Sírio- Libanês', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'ICTr', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital de Câncer de Londrina', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'city': 'Carazinho', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Caridade de Carazinho', 'geoPoint': {'lat': -28.28389, 'lon': -52.78639}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'CPO', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'HCPA', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Mãe de Deus', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Blumenau', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Clínica Reichow', 'geoPoint': {'lat': -26.91944, 'lon': -49.06611}}, {'city': 'Itajaí', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'CNT Itajaí', 'geoPoint': {'lat': -26.90778, 'lon': -48.66194}}, {'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'COI Américas', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'INCA', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'AC Camargo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'IBCC', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Providencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Fundación Arturo López Pérez', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'city': 'Chapinero', 'state': 'Bogota D.C.', 'country': 'Colombia', 'facility': 'Clínica del Country', 'geoPoint': {'lat': 4.63533, 'lon': -74.06616}}, {'city': 'Montería', 'state': 'Departamento de Córdoba', 'country': 'Colombia', 'facility': 'Oncomedica', 'geoPoint': {'lat': 8.75081, 'lon': -75.87823}}, {'city': 'Robledo', 'state': 'Medellín', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe', 'geoPoint': {'lat': 6.27626, 'lon': -75.59718}}, {'city': 'Mexico City', 'state': 'Not Aplicable', 'country': 'Mexico', 'facility': 'Centro Médico Nacional Siglo XXI', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'state': 'Not Aplicable', 'country': 'Mexico', 'facility': 'INCan', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Carlos Barrios', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Latin American Cooperative Oncology Group'}, {'name': 'Gustavo Werutsky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Latin American Cooperative Oncology Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latin American Cooperative Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}