Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04587856
Status:
RECRUITING
Last Update Posted:
2024-10-22
First Post:
2020-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD34+ blast cells modifications', 'timeFrame': 'at 24 months', 'description': 'Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.', 'detailedDescription': 'This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure.\n\nViable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence.\n\nCD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing.\n\nTo study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MDS according to 2016 WHO criteria\n* Aged 18y or older\n* Patients who will receive allogeneic stem cell transplantation (HSCT)\n* Signed written informed consent according to ICH/EU/GCP and national local laws\n\nExclusion Criteria:\n\n* Second HSCT procedure.'}, 'identificationModule': {'nctId': 'NCT04587856', 'briefTitle': 'Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': 'MDS0620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Biological evaluation', 'description': 'evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.', 'interventionNames': ['Other: bone marrow withdrawal']}], 'interventions': [{'name': 'bone marrow withdrawal', 'type': 'OTHER', 'description': 'bone marrow samples evaluation', 'armGroupLabels': ['Biological evaluation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pellegrino Musto', 'role': 'CONTACT', 'email': 'pellegrino.musto@uniba.it'}], 'facility': 'Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valeria Santini', 'role': 'CONTACT'}], 'facility': 'Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmela Di Grazia', 'role': 'CONTACT'}], 'facility': 'AOU San Martino-IST-Ematologia 1', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Mecucci', 'role': 'CONTACT'}], 'facility': 'Sezione di Ematologia - Ospedale S.Maria della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Breccia', 'role': 'CONTACT'}], 'facility': 'Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Teresa Voso', 'role': 'CONTACT'}], 'facility': 'Policlinico Tor Vergata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo E Della Porta', 'role': 'CONTACT', 'email': 'matteo.della_porta@hunimed.eu'}], 'facility': 'Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}