Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-16 @ 1:41 PM
Study NCT ID:
NCT02006004
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2013-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiologic Registry PETHEMA LMA 2013
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of the patients diagnosed with AML', 'timeFrame': '3 years', 'description': 'To realize an epidemiologic and retrospective study to assess the characteristics of the patients diagnosed with AML and their disease, regardless the age or treatment'}], 'secondaryOutcomes': [{'measure': 'Prognosis factors', 'timeFrame': '3 years', 'description': 'To correlate clinical and biological features with outcome and evolution of the patients.'}, {'measure': 'Risk factors', 'timeFrame': '3 years', 'description': 'To identify and confirm the risk factors which are involved in the evolution of the disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AML'], 'conditions': ['AML']}, 'descriptionModule': {'briefSummary': 'Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary 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 with the appropriate security.'}, '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\nPatients diagnosed with acute myeloid leukemia\n\nExclusion Criteria:\n\nno exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02006004', 'briefTitle': 'Epidemiologic Registry PETHEMA LMA 2013', 'organization': {'class': 'OTHER', 'fullName': 'PETHEMA Foundation'}, 'officialTitle': 'Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2013)', 'orgStudyIdInfo': {'id': 'PETHEMA LMA 2013'}}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Sanz Miguel Angel, DR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital La Fe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PETHEMA Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}