This retrospective-prospective observational cohort study aims to evaluate peripheral blood plasma circulating tumor DNA (ctDNA) dynamics in pediatric acute leukemia and compare ctDNA results with concurrent bone marrow multiparameter flow cytometry minimal residual disease (MFC-MRD), droplet digital PCR (ddPCR), and RNA sequencing findings. The study includes a retrospective cohort with available clinical and molecular data and a prospective cohort with serially collected peripheral blood and bone marrow samples at predefined treatment time points. The study will assess consistence between plasma ctDNA and conventional bone marrow-based assays, characterize longitudinal ctDNA dynamics, and explore the association between ctDNA patterns and relapse or survival outcomes.
Eligibility
Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients diagnosed with pediatric acute leukemia, including acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia.
2. Age younger than 18 years at diagnosis.
3. Availability of peripheral blood plasma cfDNA/ctDNA testing data.
4. Availability of clinical data and at least one corresponding bone marrow-based assessment, including MFC-MRD, ddPCR, RNA sequencing.
5. For prospectively collected follow-up data or samples, written informed consent will be obtained from parents or legal guardians.
6. For retrospectively collected data, consent procedures will follow the approval of the institutional ethics committee.
Exclusion Criteria:
1. Patients without available peripheral blood plasma cfDNA/ctDNA data.
2. Patients with insufficient clinical or laboratory data for analysis.
3. Samples failing cfDNA/ctDNA quality control.
4. Withdrawal of consent for prospective follow-up or additional sample collection.
5. Patients judged by the investigator to be unsuitable for inclusion.
Primary outcome measure(s)
Consistence between peripheral blood plasma ctDNA and bone marrow MFC-MRD — From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation. Concordance between peripheral blood plasma ctDNA status and matched bone marrow MFC-MRD results.
Trial sites (1)
Facility
City
Region
Status
Department of Pediatric Hematology/Oncology,Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
More Institute of Hematology & Blood Diseases Hospital, China 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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