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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Neutrophil engraftment
* Received at least one MRD monitoring by digital PCR after HSCT
Exclusion Criteria:
* Patients who relapsed or died before the first digital PCR monitoring
* Patients only with mutations in DNMT3A, TET2, and ASXL1 ("DTA mutations") or only germline mutations
Primary outcome measure(s)
Threshold of dPCR to predict conventional MRD — 2-year 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.
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
Recruiting
More Peking University People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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