Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:29 AM
Study NCT ID:
NCT04311060
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2020-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bone marrow samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Newly diagnosed adults patients with Acute Myeloid Leukemia will be assessed as traditionally by the treating institution using classic clinical, demographic and cytogenetic variables. Complementary molecular tests will be performed in the patients included in the study using PCR to detect classic CBF (Core Binding Factor) rearrangements: CBFB-MYH11 \\[inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS (Next Generation Sequencing) to detect mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed AML\n* Over 15 years of age\n* Flow cytometry confirmation\n* Candidate for treatment (intensive or not intensive)\n\nExclusion Criteria:\n\n* Acute Promyelocytic Leukemia\n* Mixed phenotype leukemias\n* Isolated myeloid sarcoma\n* Blastic plasmacytoid dendritic cell neoplasm'}, 'identificationModule': {'nctId': 'NCT04311060', 'briefTitle': 'Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.', 'organization': {'class': 'OTHER', 'fullName': 'Mexican Agrupation for Hematology Study'}, 'officialTitle': 'Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study', 'orgStudyIdInfo': {'id': 'HEM-3094-19-25-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Molecular panel', 'type': 'DIAGNOSTIC_TEST', 'description': '* Detection of CBF rearrangements using PCR: CBFB-MYH11 \\[inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22).\n* NGS panel to detect classic mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ixtapaluca', 'state': 'Edo Mex', 'country': 'Mexico', 'contacts': [{'name': 'Alvaro Cabrera García, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Regional de Alta Especialidad Ixtapaluca', 'geoPoint': {'lat': 19.31556, 'lon': -98.88284}}, {'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'contacts': [{'name': 'Lauro Fabián Amador Medina, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Regional de Alta Especialidad Bajío', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'contacts': [{'name': 'Andrés Gómez, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'contacts': [{'name': 'Diego Cruz Contreras, MD', 'role': 'CONTACT'}], 'facility': 'Imss Umae 25', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Ciudad Victoria', 'state': 'Tamaulipas', 'country': 'Mexico', 'contacts': [{'name': 'Ramón A Martínez Hernández, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Regional de Alta Especialidad Ciudad Victoria', 'geoPoint': {'lat': 23.74061, 'lon': -99.14364}}, {'zip': '1400', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'contacts': [{'name': 'Sue Cynthia Gómez Cortes, MD', 'role': 'CONTACT'}], 'facility': 'Centro Médico Naciona Siglo XXI IMSS', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'contacts': [{'name': 'Efreen Montaño Figueroa, MD', 'role': 'CONTACT'}], 'facility': 'Hospital General de México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'contacts': [{'name': 'Andrea Milan Salvatierra, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Juarez de México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'contacts': [{'name': 'Silvia Rivas Vera, MD', 'role': 'CONTACT'}], 'facility': 'Instituto Nacional de Cancerlogía', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Roberta Demichelis, MD', 'role': 'CONTACT', 'email': 'robertademichelis@gmail.com', 'phone': '+521555487 0900', 'phoneExt': '2700'}, {'name': 'Emmanuel Almanza Huante, MD', 'role': 'CONTACT', 'email': 'ealmanza.huante@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mexican Agrupation for Hematology Study', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, {'name': 'Instituto Nacional de Cancerologia de Mexico', 'class': 'OTHER'}, {'name': 'Centro Medico Nacional Siglo XXI IMSS', 'class': 'OTHER'}, {'name': 'Hospital General de México Dr. Eduardo Liceaga', 'class': 'OTHER_GOV'}, {'name': 'Hospital Regional de Alta Especialidad del Bajio', 'class': 'OTHER'}, {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, {'name': 'Hospital Regional de Alta Especialidad de Ciudad Victoria Bicentenario 2010', 'class': 'OTHER'}, {'name': 'Hospital Juarez de Mexico', 'class': 'OTHER_GOV'}, {'name': 'Hospital Regional de Alta especialidad de Ixtapaluca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}