Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-04 @ 1:35 PM
Study NCT ID:
NCT02990104
Status:
UNKNOWN
Last Update Posted:
2016-12-13
First Post:
2016-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Report, Five Years Experience of the Acute Leukemia Work Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals', 'timeFrame': '5 years', 'description': 'Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals'}], 'secondaryOutcomes': [{'measure': 'Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals', 'timeFrame': '5 years', 'description': 'Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Leukemia (Category)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.', 'detailedDescription': 'Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute Lymphoblastic Leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Acute Lymphoblastic Leukemia\n\nExclusion Criteria none'}, 'identificationModule': {'nctId': 'NCT02990104', 'acronym': 'PR-GTLA', 'briefTitle': 'First Report, Five Years Experience of the Acute Leukemia Work Group', 'organization': {'class': 'OTHER', 'fullName': 'Mexican Agrupation for Hematology Study'}, 'officialTitle': 'Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)', 'orgStudyIdInfo': {'id': '2016001/PR-GTLA'}}, 'contactsLocationsModule': {'locations': [{'zip': '1400', 'city': 'Mexico City', 'state': 'Mexico Distrito Federal', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Roberta Demichelis, Doctor', 'role': 'CONTACT', 'email': 'robertademichelis@gmail.com', 'phone': '015554870900', 'phoneExt': '2700'}, {'name': 'Karla Espinoza, Doctor', 'role': 'CONTACT', 'phone': '015556280400', 'phoneExt': '60035'}], 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Dra. Roberta Demichelis, Doctor', 'role': 'CONTACT', 'email': 'robertademichelis@gmail.com', 'phone': '015554870900', 'phoneExt': '2700'}, {'name': 'Dra. Karla Espinoza, Doctor', 'role': 'CONTACT', 'phone': '015556280400'}], 'overallOfficials': [{'name': 'Dr. Erick Crespo, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Hospital High Speciality, Tamaulipas Cd. Victoria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mexican Agrupation for Hematology Study', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}