Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT02861651
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017422', 'term': 'Sequence Analysis, DNA'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-08-05', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular characterization of AML-6 by NGS and CGH array', 'timeFrame': '1 year', 'description': 'Molecular characterization using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AML-6 treated at Institut Paoli-Calmettes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 year\n* Diagnosis of AML6\n* Written consent obtained\n\nExclusion Criteria:\n\n* No written consent\n* No frozen samples'}, 'identificationModule': {'nctId': 'NCT02861651', 'briefTitle': 'Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'orgStudyIdInfo': {'id': 'M6-AML-14-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA sequencing', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'state': 'Bouches-du Rhône', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Véronique Gelsi-Boyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}