Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 3:07 PM
Study NCT ID:
NCT02320656
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)', 'timeFrame': 'up to 8 years'}], 'secondaryOutcomes': [{'measure': 'Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)', 'timeFrame': 'up to 8 years'}, {'measure': 'Compare cancer and non-tumor cells genome', 'timeFrame': 'up to 8 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Leukemia', 'Myelodysplastic Syndromes', 'Myeloproliferative Disorders']}, 'referencesModule': {'references': [{'pmid': '38954834', 'type': 'DERIVED', 'citation': 'Grenier JMP, Testut C, Bal M, Bardin F, De Grandis M, Gelsi-Boyer V, Vernerey J, Delahaye M, Granjeaud S, Zemmour C, Spinella JF, Chavakis T, Mancini SJC, Boher JM, Hebert J, Sauvageau G, Vey N, Schwaller J, Hospital MA, Fauriat C, Aurrand-Lions M. Genetic deletion of JAM-C in preleukemic cells rewires leukemic stem cell gene expression program in AML. Blood Adv. 2024 Sep 10;8(17):4662-4678. doi: 10.1182/bloodadvances.2023011747.'}, {'pmid': '34050021', 'type': 'DERIVED', 'citation': 'Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.'}]}, 'descriptionModule': {'briefSummary': 'HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.\n\nHEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:\n\n* tumor samples: marrow aspiration, blood sampling.\n* non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute leukemia, myelodysplastic syndrome or myeloproliferative disease\n* age \\> 18\n* affiliated to the French Social Security Systm\n* signed informed consent\n\nExclusion Criteria:\n\n* emergency\n* patients deprived of liberty or placed under the authority of a tutor'}, 'identificationModule': {'nctId': 'NCT02320656', 'acronym': 'HEMATO-BIO', 'briefTitle': 'Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015', 'orgStudyIdInfo': {'id': 'HEMATO-BIO-IPC-2013-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute leukemia/myelodysplastic or myeloproliferative disease', 'interventionNames': ['Other: Blood sampling', 'Other: Bone marrow aspirate', 'Other: Skin biopsy', 'Other: Buccal swab']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Longitudinal (3 stages of the disease)', 'armGroupLabels': ['Acute leukemia/myelodysplastic or myeloproliferative disease']}, {'name': 'Bone marrow aspirate', 'type': 'OTHER', 'description': 'Longitudinal (3 stages of the disease)', 'armGroupLabels': ['Acute leukemia/myelodysplastic or myeloproliferative disease']}, {'name': 'Skin biopsy', 'type': 'OTHER', 'description': 'Single biopsy (optional)', 'armGroupLabels': ['Acute leukemia/myelodysplastic or myeloproliferative disease']}, {'name': 'Buccal swab', 'type': 'OTHER', 'description': 'Single sampling.', 'armGroupLabels': ['Acute leukemia/myelodysplastic or myeloproliferative disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Norbert VEY, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Dominique Genre, MD', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '+33491223778'}, {'name': 'Jihane Pakradouni, PharmD,PhD', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '+33491223778'}], 'overallOfficials': [{'name': 'Norbert Vey, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}