Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-27 @ 6:58 AM
Study NCT ID:
NCT06211166
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'bone marrow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Threshold of dPCR to predict conventional MRD', 'timeFrame': '2-year', 'description': 'To establish an optimal threshold for digital PolyTo establish an optimal threshold for digital Polymerase Chain Reaction (dPCR) in predicting Measurable Residual Disease (MRD) recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT). MRD recurrence is defined as the reappearance or elevation of minimal residual disease, as assessed by other MRD monitoring methods such as conventional quantitative PCR or multi-color Flow Cytometry (MFC), which served as indications of pre-emptive intervention by current consensus or guideline.'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of relapse (CIR)', 'timeFrame': '2-year', 'description': 'The interval from the transplantation date to hematological recurrence'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2-year', 'description': 'The time from HSCT to the Death from any cause'}, {'measure': 'Relapse-free survival (RFS)', 'timeFrame': '2-year', 'description': 'The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence'}, {'measure': 'Non-Relapse Mortality(NRM)', 'timeFrame': '2-year', 'description': 'The time from the date of HSCT to deaths that result from complications other than a relapse of the underlying disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dPCR', 'MRD', 'allo-HSCT', 'leukemia'], 'conditions': ['Acute Leukemia', 'MDS', 'MDS/MPN', 'CML']}, 'descriptionModule': {'briefSummary': 'A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.', 'detailedDescription': 'This prospective clinical study focuses on patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions post-allogeneic hematopoietic stem cell transplantation. The primary objective is to assess the efficacy of digital Polymerase Chain Reaction (dPCR) in monitoring measurable residual disease (MRD), including markers such as BCR::ABL, KMT2A, etc., as compared to other MRD monitoring methods such as conventional quantitative PCR or multicolor Flow Cytometry (MFC). Key endpoints include the recurrence of MRD using conventional methods, hematological relapse, disease-free survival, overall survival, and non-relapse mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD monitoring peri-HSCT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.\n* Neutrophil engraftment\n* Received at least one MRD monitoring by digital PCR after HSCT\n\nExclusion Criteria:\n\n* Patients who relapsed or died before the first digital PCR monitoring\n* Patients only with mutations in DNMT3A, TET2, and ASXL1 ("DTA mutations") or only germline mutations'}, 'identificationModule': {'nctId': 'NCT06211166', 'briefTitle': 'Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD', 'orgStudyIdInfo': {'id': '2021PHA154-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Leukemia', 'description': 'Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia', 'interventionNames': ['Diagnostic Test: Digital PCR', 'Diagnostic Test: Quantitative PCR', 'Diagnostic Test: MFC']}, {'label': 'MDS or MDS/MPN', 'description': 'Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm', 'interventionNames': ['Diagnostic Test: Digital PCR', 'Diagnostic Test: Quantitative PCR', 'Diagnostic Test: MFC']}, {'label': 'CML', 'description': 'Chronic Myeloid Leukemia', 'interventionNames': ['Diagnostic Test: Digital PCR', 'Diagnostic Test: Quantitative PCR']}], 'interventions': [{'name': 'Digital PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'digital Polymerase Chain Reaction (dPCR)', 'armGroupLabels': ['Acute Leukemia', 'CML', 'MDS or MDS/MPN']}, {'name': 'Quantitative PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Real-time Polymerase Chain Reaction (real-time PCR)', 'armGroupLabels': ['Acute Leukemia', 'CML', 'MDS or MDS/MPN']}, {'name': 'MFC', 'type': 'DIAGNOSTIC_TEST', 'description': 'Multicolor Flow Cytometry', 'armGroupLabels': ['Acute Leukemia', 'MDS or MDS/MPN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zi-qi Han, BS', 'role': 'CONTACT', 'email': 'ncrch_pku@163.com', 'phone': '+861088324577'}, {'name': 'Xiao-jun Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meng Lv, M.D, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ya-zhen Qin, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiao-su Zhao, M.D,Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jing Liu, M.D,Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ying-jun Chang, M.D,Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Meng Lv, M.D,Ph.D', 'role': 'CONTACT', 'email': 'drlvmeng@163.com', 'phone': '+861088324637'}, {'name': 'Ya-zhen Qin, Ph.D', 'role': 'CONTACT', 'email': 'qin2000@aliyun.com', 'phone': '+861088324702'}], 'overallOfficials': [{'name': 'Xiao-jun Huang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao-Jun Huang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}