Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-14 @ 5:39 AM
Study NCT ID:
NCT06715267
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications (VYP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2038-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2038-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the epidemiological characteristics of the study population', 'timeFrame': 'at enrollment', 'description': 'Description of MPN subtypes according to age'}, {'measure': 'Describe the mutational landscape of these MPNs', 'timeFrame': 'at enrollment', 'description': 'Rate of mutations JAK2/CALR/MPL'}], 'secondaryOutcomes': [{'measure': 'Describe the classical MPN (Myeloproliferative neoplasia) outcomes-1', 'timeFrame': 'At 10 years', 'description': 'Incidence of thrombosis'}, {'measure': 'Describe the classical MPN outcomes-2', 'timeFrame': 'At 10 years', 'description': 'Incidence of myelofibrosis'}, {'measure': 'Describe the classical MPN outcomes-3', 'timeFrame': 'At 10 years', 'description': 'Incidence of MDS/AML'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloproliferative Neoplasm']}, 'descriptionModule': {'briefSummary': 'The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. It will also make it possible to identify the biological samples (histological and molecular) available in routine laboratories, enabling teams of researchers and anatomopathologists to (re)perform certain analyses to re-evaluate diagnoses and search for hitherto unknown molecular prognostic factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with non-LMC myeloproliferative neoplasm before age 30 (Polycythemia vera, essential thrombocythemia, primary myelofibrosis, prefibrotic myelofibrosis).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with non-LMC MPN before the age of 30 (PV or TE or MFP or PreMF) according to the 2016 WHO criteria.\n* Signature of the consent form for participation in the FIMBANK project.\n* Agreement to participate in the VYP study.\n* Patient of legal age at the time of inclusion in VYP.\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Refusal to participate by patients of full age\n* Patient under legal protection (guardianship, curatorship, etc.)'}, 'identificationModule': {'nctId': 'NCT06715267', 'acronym': 'VYP', 'briefTitle': 'Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications (VYP)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications', 'orgStudyIdInfo': {'id': '29BRC23.0018 - VYP'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Jean-Christophe IANOTTO', 'role': 'CONTACT', 'email': 'jean-christophe.ianotto@chu-brest.fr', 'phone': '0298223786', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}