Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06116318
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2023-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CIR', 'timeFrame': 'Within 5 years after treatment', 'description': 'cumulative incidence of recurrence'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'Within 5 years after treatment', 'description': 'Overall Survival Rate'}, {'measure': 'RFS', 'timeFrame': 'Within 5 years after treatment', 'description': 'Relapse-free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute myeloid leukemia', 'c-Kit mutation', 'MRD'], 'conditions': ['C-KIT Mutation']}, 'descriptionModule': {'briefSummary': 'C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute myeloid leukemia confirmed by bone marrow cell morphology, immunology, and genetics. And c-Kit D816 mutation was positive.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.\n\nExclusion Criteria:\n\nPatients with other factors which were considered unsuitable to participate in the study by the investigators'}, 'identificationModule': {'nctId': 'NCT06116318', 'briefTitle': 'A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Absolute Quantification of c-Kit Mutation as MRD in Acute Myeloid Leukemia: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'QT2023009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MRD negative', 'description': 'c-Kit mutation tested negative'}, {'label': 'MRD L1', 'description': 'MRD detection at low level-1：\\<0.001%'}, {'label': 'MRD L2', 'description': 'MRD detection at low level-2：0.001%≤c-Kit MRD\\<0.01%'}, {'label': 'MRD L3', 'description': 'detection at low level-3：0.01%≤c-Kit MRD\\<0.1%'}, {'label': 'MRD positive', 'description': 'MRD positive：c-Kit MRD≥0.1%'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Wei, MD', 'role': 'CONTACT'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Hui Wei, Doctor', 'role': 'CONTACT', 'email': 'weihui@ihcams.ac.cn', 'phone': '13132507161'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}