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Trial Title:
A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia
NCT ID:
NCT06116318
Condition:
C-KIT Mutation
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Acute myeloid leukemia
c-Kit mutation
MRD
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Patients with acute myeloid leukemia confirmed by bone marrow cell morphology,
immunology, and genetics. And c-Kit D816 mutation was positive.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816
mutation. And receive treatment.
Exclusion Criteria:
Patients with other factors which were considered unsuitable to participate in the study
by the investigators
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wei, MD
Start date:
November 1, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116318
