Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-27 @ 5:17 PM
Study NCT ID:
NCT01877902
Status:
UNKNOWN
Last Update Posted:
2014-12-05
First Post:
2013-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-25', 'releaseDate': '2015-06-08'}, {'resetDate': '2015-09-02', 'releaseDate': '2015-08-04'}, {'resetDate': '2015-10-30', 'releaseDate': '2015-09-30'}, {'resetDate': '2019-03-01', 'releaseDate': '2019-02-21'}], 'estimatedResultsFirstSubmitDate': '2015-06-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine utilization profile (line treatment and scheme used) of pemetrexed in patients with non-small cell lung cancer metastatic (CPNMm) in Andalusia.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': '1) Determine the progression-free survival and overall survival 2) Evaluate the degree of adherence in prescribing pemetrexed patients with CPNMm in Andalusia approved indications, the recommendations of the Pharmacy and Therapeutics Committees and', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'It will be included all patients diagnosed CPNMm participating centers to initiate treatment with pemetrexed in 1st line (either induction or maintenance.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years\n* Confirmed diagnosis of metastatic NSCLC\n* Pemetrexed Starts 1st line (either induction or maintenance) in any of the following periods:\n* January 1, 2010 to March 31, 2010\n* October 1, 2011 to December 31, 2011\n\nExclusion Criteria:\n\n* Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.'}, 'identificationModule': {'nctId': 'NCT01877902', 'briefTitle': 'Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System', 'organization': {'class': 'OTHER', 'fullName': 'Andalusian Network for Design and Translation of Advanced Therapies'}, 'officialTitle': 'STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM', 'orgStudyIdInfo': {'id': 'FPS-PEM-2013-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pemetrexed 500 mg/m 2'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Algeciras', 'state': 'Cádiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Carlos Roldán', 'role': 'CONTACT'}], 'facility': 'Hospital La Línea', 'geoPoint': {'lat': 36.13326, 'lon': -5.45051}}, {'city': 'Algeciras', 'state': 'Cádiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo Villanueva Jiménez', 'role': 'CONTACT'}], 'facility': 'Hospital Punta de Europa', 'geoPoint': {'lat': 36.13326, 'lon': -5.45051}}, {'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rocío Gavira Moreno', 'role': 'CONTACT'}], 'facility': 'Hospital Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'city': 'Marbella', 'state': 'Cádiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Margarita Garrido', 'role': 'CONTACT'}], 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'city': 'Puerto Real', 'state': 'Cádiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carmen Martínez Díaz', 'role': 'CONTACT'}], 'facility': 'Hospital de Puerto Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'city': 'Baza', 'state': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Nieto Cobo', 'role': 'CONTACT'}], 'facility': 'Hospital de Baza', 'geoPoint': {'lat': 37.49073, 'lon': -2.77259}}, {'city': 'Almería', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan José Fernández Avila', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Torrecardenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Cadiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María José Martínez Bautista', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Isabel Gago Sánchez', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miguel Damas Fernández Fijares', 'role': 'CONTACT'}], 'facility': 'Hospital San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marcos Camacho Romera', 'role': 'CONTACT'}], 'facility': 'Hospital Santa Ana', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Inmaculada Vallejo Rodríguez', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Huelva', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mª Teresa Garrido Martínez', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Beatriz Mora Rodríguez', 'role': 'CONTACT'}], 'facility': 'Hospital Regional de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Begoña Muros de Fuentes', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Artecho', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Bautista Paloma', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Nuria Muñoz Muñoz', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Javier Bautista Paloma', 'role': 'CONTACT', 'phone': '955 01 20 00'}, {'name': 'María del Mar Benjumea Vargas', 'role': 'CONTACT', 'email': 'gestiondeensayosclinicos.fps@juntadeandalucia.es'}], 'overallOfficials': [{'name': 'Javier Bautista Paloma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitales Universitarios Virgen del Rocío'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza Progreso y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-06-08', 'type': 'RELEASE'}, {'date': '2015-06-25', 'type': 'RESET'}, {'date': '2015-08-04', 'type': 'RELEASE'}, {'date': '2015-09-02', 'type': 'RESET'}, {'date': '2015-09-30', 'type': 'RELEASE'}, {'date': '2015-10-30', 'type': 'RESET'}, {'date': '2019-02-21', 'type': 'RELEASE'}, {'date': '2019-03-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Fundación Pública Andaluza Progreso y Salud'}}}}