Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 12:20 PM
Study NCT ID:
NCT06000306
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2023-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018365', 'term': 'Neoplasm, Residual'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-08-11', 'studyFirstSubmitQcDate': '2023-08-12', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of relapse (CIR)', 'timeFrame': 'At Year 2', 'description': 'The time from the date of transplantation to disease recurrence:\n\nDisease recurrence, defined as one of the following:\n\nLeukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.'}], 'secondaryOutcomes': [{'measure': 'Relapse-free survival (RFS)', 'timeFrame': 'At Year 2', 'description': 'The time from the date of treatment to the occurrence of any of the following:\n\n1. Death from any cause\n2. Disease recurrence'}, {'measure': 'Non-relapse mortality (NRM)', 'timeFrame': 'At Year 2', 'description': 'Assessment of NRM at Year 2'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'At Year 2', 'description': 'Assessment of OS at Year 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['droplet digital PCR', 'allogeneic hematopoietic stem cell transplantation', 'relapse'], 'conditions': ['Measurable Residual Disease']}, 'referencesModule': {'references': [{'pmid': '38689269', 'type': 'DERIVED', 'citation': 'Chen W, Huang J, Zhao Y, Huang L, Yuan Z, Gu M, Xu X, Shi J, Luo Y, Yu J, Lai X, Liu L, Fu H, Bao C, Huang X, Zheng Z, Huang H, Hu X, Zhao Y. Measurable residual disease monitoring by ddPCR in the early posttransplant period complements the traditional MFC method to predict relapse after HSCT in AML/MDS: a multicenter retrospective study. J Transl Med. 2024 Apr 30;22(1):410. doi: 10.1186/s12967-024-05114-w.'}]}, 'descriptionModule': {'briefSummary': 'A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse', 'detailedDescription': 'This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring;\n2. Successful stem cell engraftment\n3. Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;\n4. Age 12-70\n\nExclusion Criteria:\n\n1. Patients who relapsed or died before the first ddPCR monitoring;\n2. Patients with only germline mutations.'}, 'identificationModule': {'nctId': 'NCT06000306', 'briefTitle': 'MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse', 'orgStudyIdInfo': {'id': 'IIT20230588C-R1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ddPCR MRD positivity', 'interventionNames': ['Diagnostic Test: Digital Droplet PCR']}, {'label': 'ddPCR MRD negativity', 'interventionNames': ['Diagnostic Test: Digital Droplet PCR']}], 'interventions': [{'name': 'Digital Droplet PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period', 'armGroupLabels': ['ddPCR MRD negativity', 'ddPCR MRD positivity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Hospital of Zhejiang Medical Colleage Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The President of The First Affiliated Hospital, College of Medicine, Zhejiang University', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}