RecruitingNCT06211166

Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction

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


Sponsor

Peking University People's Hospital

Enrollment

300 participants

Start Date

Jan 8, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Inclusion Criteria3

  • 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 Criteria2

  • 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

Interventions

DIAGNOSTIC_TESTDigital PCR

digital Polymerase Chain Reaction (dPCR)

DIAGNOSTIC_TESTQuantitative PCR

Real-time Polymerase Chain Reaction (real-time PCR)

DIAGNOSTIC_TESTMFC

Multicolor Flow Cytometry


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06211166


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