Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT05074316
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2021-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Myeloid Neoplasms Biology and Outcome Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'clinically and molecularly annotated biospecimens are collected and stored within the biobank structures of the Department of Internal Medicine V of the Heidelberg University Hospital including blood and bone marrow samples, plasma and serum including liquid biopsies (cfDNA).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'median overall survival (mOS)', 'timeFrame': '5 years', 'description': 'Time period of survival from date of diagnosis of myeloid neoplasy'}, {'measure': 'overall survival (mOS)', 'timeFrame': '10 years', 'description': 'Time period of survival from date of diagnosis of myeloid neoplasy'}, {'measure': 'event free survival (EFS)', 'timeFrame': '5 years', 'description': 'Time period of event free survival from date of diagnosis of myeloid neoplasy'}, {'measure': 'progression free survival (PFS)', 'timeFrame': '5 years', 'description': 'Time period of progression survival from date of diagnosis of myeloid neoplasy'}], 'secondaryOutcomes': [{'measure': 'Questionnaire for the health- related quality of life QLQ-C30', 'timeFrame': '5 years', 'description': 'Standardized Quality of Life Assessment, Higher values are better'}, {'measure': 'Questionnaire for physical, cognitive and emotional aspects of cancer-related fatigue QLQ-FA12', 'timeFrame': '5 years', 'description': 'Standardized Quality of Fatigue, Higher values are worse'}, {'measure': 'Questionnaire for anxiety and depression PHQ-4', 'timeFrame': '5 years', 'description': 'Standardized Quality of anxiety and depression, Higher values are worse'}, {'measure': 'Functional Assessment of Cancer Therapy Fact-Cog', 'timeFrame': '5 years', 'description': 'Standardized Quality of cognitive function, Higher values are better'}, {'measure': 'The Pittsburgh Sleep Quality Index PSQI', 'timeFrame': '5 years', 'description': 'Standardized Quality of sleep, Higher values are worse'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outcome project', 'registry'], 'conditions': ['Myeloid Neoplasm']}, 'descriptionModule': {'briefSummary': 'The Myeloid Neoplasms Biology and Outcome Project (MyBOP) aims to establish a registry study for patients with myeloid neoplasms. It integrates clinical data, biological samples, socio-demographic information, long-term follow-up and patient reported outcomes in a structured manner for scientific purposes.\n\nThe ultimate benefits are:\n\n1. Improvement of evidence-based clinical management of patients with myeloid neoplasms through better understanding of the course of disease and prognostic and predictive parameters\n2. Direct access to new and personalized treatment approaches through recruitment into clinical studies based on the myeloid neoplasms study platform\n3. Quality assurance of participating centers by evaluating and comparing clinical outcomes and side effects of the MyBOP patients with published data.', 'detailedDescription': 'During recent years, considerable progress has been made in deciphering the molecular genetic and epigenetic basis of myeloid neoplasms and in defining new diagnostic and prognostic as well as predictive markers. Myeloid neoplasms are categorized according to the current WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues based on the revision of 2016 \\[1\\]. This includes Myeloproliferative neoplasms (MPN), Mastocytosis, Myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK2, Myelodysplastic/myeloproliferative neoplasms (MDS/MPN), Myelodysplastic syndromes (MDS), Myeloid neoplasms with germ line predisposition, Acute myeloid leukemia (AML) and related neoplasms (i.e. Myeloid sarcoma and Myeloid proliferations related to Down syndrome), Blastic plasmacytoid dendritic cell neoplasm and Acute leukemia of ambiguous lineage (Table 1).\n\nA growing number of recurring genetic changes are recognized in the current WHO 2016 classification of myeloid neoplasms \\[2\\] and additional molecularly defined subgroups as well as new entities are expected to be included in future versions. Furthermore, novel therapies are now available and being developed, which target specific genetic lesions, and several surface antigens are being explored as targets for immunotherapy-based treatment strategies, e.g. CAR-T-cell therapy \\[3\\].\n\nAlthough the WHO 2016 classification represents an enormous progress in terms of reliability, validity and objectivity, there are still huge diagnostic uncertainties left \\[4-18\\] and the field of targeted therapy \\[19-25\\] in myeloid neoplasms is just at its beginning. Furthermore, clonal evolution and transition from one entity to another is a clinically relevant issue \\[26-30\\].\n\nThus, key areas of interest are:\n\n* Systematic collection and evaluation of comprehensive clinical information from patients with myeloid neoplasm, including morphomolecular disease subtype, as well as drug treatments, radiation therapy, surgical procedures and long-term follow-up data\n* Systematic collection and evaluation of comprehensive biological specimens and information from patients with myeloid neoplasms, including data on the genomic, transcriptomic, epigenomic and proteomic "landscapes" as well as expression of surface antigens of myeloid disease subtypes, to identify novel prognostic and predictive parameters as well as entry points for targeted therapeutic interventions\n* Regular assessment of patient reported outcomes\n\nThe above challenges are ideally met by a registry study with a sufficient population size in order to answer relevant questions in rare cancer entities. The aim is to set up a registry study that covers systematic and comprehensive clinical data acquisition. In addition, the banking of tumor and germline samples from patients with myeloid neoplasms is intended by all patients. This resource will spur patient-oriented investigations into relationships between clinical and biological parameters in myeloid neoplasms and lay the groundwork for novel, molecular mechanism- and immunotherapy-based treatment approaches in poorly understood and difficult-to-treat subsets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the patient cohort will be selected from the University Hospital Heidelberg.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected or proven diagnosis of Myeloid Neoplasms according to the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues\n* Age ≥18 years\n* Ability to understand the nature and individual consequences of the registry\n* Written informed consent\n* Subjects who are physically or mentally capable of giving consent\n\nExclusion Criteria:\n\nSevere neurological or psychiatric disorder interfering with the ability to give written informed consent'}, 'identificationModule': {'nctId': 'NCT05074316', 'acronym': 'MyBOP', 'briefTitle': 'The Myeloid Neoplasms Biology and Outcome Project', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients With Myeloid Neoplasms', 'orgStudyIdInfo': {'id': 'MyBOP'}}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Editha Gnutzmann', 'role': 'CONTACT', 'email': 'editha.gnutzmann@med.uni-heidelberg.de', 'phone': '+4962215636235'}], 'facility': 'UHHeidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Editha Gnutzmann, M.A.', 'role': 'CONTACT', 'email': 'editha.gnutzmann@med.uni-heidelberg.de', 'phone': '+49 6221 56 36235'}], 'overallOfficials': [{'name': 'Richard F Schlenk, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg, Department of Internal Medicine V, German Cancer Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of NCT trials center and Clinical Trials Office Hematology/Oncology', 'investigatorFullName': 'Prof. Dr. Richard F Schlenk', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}