Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-02 @ 7:51 AM
Study NCT ID:
NCT06905704
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Stem Cell Donation on Unrelated and Related Donors' Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety of stem cell donation', 'timeFrame': 'From enrollment to 30 days after stem cell donation', 'description': 'The proportion of overall serious adverse reactions/events (number of patient-reactions out of the total number of patients)'}], 'secondaryOutcomes': [{'measure': 'peripheral stem cells analysis', 'timeFrame': 'From enrollment to 30 days after stem cell donation', 'description': 'Measurement of blood counts and CD34+ cells pre-donation and in the collected product'}, {'measure': 'lymphocyte analysis', 'timeFrame': 'From enrollment to 30 days after stem cell donation', 'description': 'Cytofluorimetric analysis of lymphocyte subpopulations (CD4, CD8, CD4/8 ratio) at donor enrollment'}, {'measure': 'CBC analysis', 'timeFrame': 'From enrollment to 30 days after stem cell donation', 'description': 'CBC examination at different measurement times'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stem cell donors, safety, transplantation'], 'conditions': ['Stem Cell Donors']}, 'descriptionModule': {'briefSummary': 'Haematopoietic stem cell donation represents a unique chance for curing patients affected with onchohaematologic and inherited diseases.If a related donor is unavailable a unrelated donor must be used. For both categories an accurate physical and laboratory examination is mandatory to establish the eligibility to bone marrow or peripheral blood stem cell collection since side effects related to donation may occur. To ensure high standards of safety and satisfaction of unrelated stem cells donors dedicated guidelines are available. On the other hand, there is no unambiguous guidance on the management of the related donor and published data on donation and long term follow-up are scarce.', 'detailedDescription': 'The study, for the retrospective part, aims to report the experience in family and registry donor management at Transfusion Service from 2016 to 2022 (enrollment, stem cell donation, 30-day follow-up) and, for the prospective part, to continue monitoring on donors who will be enrolled in the next five years (2023 to 2028).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'stem cell donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Family donors ≥18 years referred by the Hematology and Oncohematology Transplant Center Pediatric of the Foundation of Centro Donatori -SIMT, following the national and international guidelines after medical evaluation\n* Volunteer donors from IBMDR registry ≥18 years, following the national and international guidelines after medical evaluation\n\nExclusion Criteria:\n\n* Donors 18 \\< years'}, 'identificationModule': {'nctId': 'NCT06905704', 'acronym': 'HPCDON', 'briefTitle': "Impact of Stem Cell Donation on Unrelated and Related Donors' Health.", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': "Retrospective-prospective Observational Monocentric Study Evaluating the Impact of Stem Cell Donation on Unrelated and Related Donors' Health.", 'orgStudyIdInfo': {'id': 'HPCDON'}}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudia Del Fante', 'role': 'CONTACT', 'email': 'c.delfante@smatteo.pv.it', 'phone': '+390382503306'}], 'facility': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Claudia Del Fante, MD', 'role': 'CONTACT', 'email': 'c.delfante@smatteo.pv.it', 'phone': '+390382503306'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Claudia Del Fante', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}