Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-07 @ 9:19 PM
Study NCT ID:
NCT03156933
Status:
UNKNOWN
Last Update Posted:
2017-05-17
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative Splicing and Leukemia Initiating Cells
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_WITHOUT_DNA', 'description': 'RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polymerase chain reaction', 'timeFrame': '1 month', 'description': 'Transcriptome analysis to determine the splicing variants on acute myeloid leukaemia initiator cells.\n\nThe analysis will focus on the gene encoding ABCA3 transporter and genes known to be mutated in patients with acute myeloid leukemia (FLT3, NPM1, c-Kit, N et K-RAS).\n\nThe duration of selection of samples is estimated to be one month.'}, {'measure': 'Ribonucleic acid sequencing', 'timeFrame': '1 month', 'description': 'Transcriptome analysis to determine the splicing variants on acute myeloid leukaemia initiator cells.\n\nThe analysis will focus on the gene encoding ABCA3 transporter and genes known to be mutated in patients with acute myeloid leukemia (FLT3, NPM1, c-Kit, N et K-RAS).\n\nThe duration of selection of samples is estimated to be one month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML.\n\nAML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs).\n\nThe aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with 11q23 acute myeloid leukaemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years-old\n* Patients treated at the south lyon hospital center\n* Patients with a diagnosis of acute myeloid leukemia confirmed in cytology and whose involvement of the 11q23 locus was confirmed by in situ hybridization\n* Patients for whom a sample is available in the cytogenetic laboratory of the south lyon hospital center\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03156933', 'acronym': 'ASLIC', 'briefTitle': 'Alternative Splicing and Leukemia Initiating Cells', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Alternative Splicing and Leukemia Initiating Cells', 'orgStudyIdInfo': {'id': '69HCL16_0800'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Splicing variants', 'description': 'Sample of acute myeloid leukaemia primary cells', 'interventionNames': ['Other: Assessment of splicing variants']}], 'interventions': [{'name': 'Assessment of splicing variants', 'type': 'OTHER', 'description': 'This is a biological study with primary samples without any intervention on patients.', 'armGroupLabels': ['Splicing variants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne PAUBELLE, MD, PhD', 'role': 'CONTACT', 'email': 'Etienne.paubelle@chu-lyon.fr', 'phone': '04 78 86 22 50', 'phoneExt': '+33'}, {'name': 'Erice WATTEL, MD, PhD', 'role': 'CONTACT', 'email': 'eric.wattel@chu-lyon.fr', 'phone': '04 78 86 22 60', 'phoneExt': '+33'}], 'facility': "Service d'hématologie du Centre Hospitalier Lyon Sud", 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Etienne PAUBELLE, MD, PhD', 'role': 'CONTACT', 'email': 'Etienne.paubelle@chu-lyon.fr', 'phone': '04 78 86 22 50', 'phoneExt': '+33'}, {'name': 'Eric WATTEL, MD, PhD', 'role': 'CONTACT', 'email': 'eric.wattel@chu-lyon.fr', 'phone': '04 78 86 22 60', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Etienne PAUBELLE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'hématologie du Centre Hospitalier Lyon Sud"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}