Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 10:09 PM
Study NCT ID:
NCT05755633
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2023-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients', 'timeFrame': 'day 60 after transplant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem']}, 'descriptionModule': {'briefSummary': 'The rationale of this study is to determine if an association exists between WT1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. In particular, we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients.', 'detailedDescription': 'This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria. For each patient a total of 24 ml of bone marrow was collected at day +60 post transplant, whereas the same quantity of bone marrow was collected from healthy donor during bone marrow harvest procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant.\n\nThe minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years Diagnosis of acute myeloid leukemia Patients received allogeneic stem cell transplantation Signed informed consent to storage and use biological samples for research scope Signed informed consent to privacy\n\nExclusion Criteria:\n\n* Patients who had received a previous stem cell transplant Hematological disease other than acute myeloid leukemia Patient not studied for WT1 level at day +60 after transplant'}, 'identificationModule': {'nctId': 'NCT05755633', 'briefTitle': 'Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '4065'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Servizio E Dh Di Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'CHIUSOLO PATRIZIA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}