Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 9:36 PM
Study NCT ID:
NCT02607059
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiologic Registry PETHEMA LMA 2015
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'characteristics of the patients diagnosed of AML', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['AML']}, 'referencesModule': {'references': [{'pmid': '38896056', 'type': 'DERIVED', 'citation': 'Labrador J, Martinez-Cuadron D, Boluda B, Serrano J, Gil C, Perez-Simon JA, Bernal T, Bergua JM, Martinez-Lopez J, Rodriguez-Medina C, Vidriales MB, Garcia-Boyero R, Algarra L, Polo M, Sayas MJ, Tormo M, Alonso-Dominguez JM, Herrera P, Lavilla E, Ramos F, Amigo ML, Vives-Polo S, Rodriguez-Macias G, Mena-Duran A, Perez-Encinas MM, Arce-Fernandez O, Cuello R, Sanchez-Garcia J, Gomez-Casares MT, Chillon MC, Calasanz MJ, Ayala R, Rodriguez-Veiga R, Barragan E, Montesinos P; PETHEMA Group. Evolving patterns and clinical outcome of genetic studies performed at diagnosis in acute myeloid leukemia patients: Real life data from the PETHEMA Registry. Cancer. 2024 Oct 15;130(20):3436-3451. doi: 10.1002/cncr.35431. Epub 2024 Jun 19.'}, {'pmid': '34794172', 'type': 'DERIVED', 'citation': 'Martinez-Cuadron D, Megias-Vericat JE, Serrano J, Martinez-Sanchez P, Rodriguez-Arboli E, Gil C, Aguiar E, Bergua J, Lopez-Lorenzo JL, Bernal T, Espadana A, Colorado M, Rodriguez-Medina C, Lopez-Pavia M, Tormo M, Algarra L, Amigo ML, Sayas MJ, Labrador J, Rodriguez-Gutierrez JI, Benavente C, Costilla-Barriga L, Garcia-Boyero R, Lavilla-Rubira E, Vives S, Herrera P, Garcia-Belmonte D, Herraez MM, Vasconcelos Esteves G, Gomez-Roncero MI, Cabello A, Bautista G, Balerdi A, Mariz J, Boluda B, Sanz MA, Montesinos P. Treatment patterns and outcomes of 2310 patients with secondary acute myeloid leukemia: a PETHEMA registry study. Blood Adv. 2022 Feb 22;6(4):1278-1295. doi: 10.1182/bloodadvances.2021005335.'}]}, 'descriptionModule': {'briefSummary': 'Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach', 'detailedDescription': 'To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with acute myeloid leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acute myeloid leukemia\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02607059', 'briefTitle': 'Epidemiologic Registry PETHEMA LMA 2015', 'organization': {'class': 'OTHER', 'fullName': 'PETHEMA Foundation'}, 'officialTitle': 'Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2015)', 'orgStudyIdInfo': {'id': 'LAM 2015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Registry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pau Montesinos, Dr', 'role': 'CONTACT', 'email': 'montesinos_pau@gva.es'}], 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Pau Montesinos, Dr', 'role': 'CONTACT', 'email': 'montesinos_pau@gva.es'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PETHEMA Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}