Plasma ctDNA Monitoring in Pediatric Acute Leukemia

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Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT07751588

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

25

Starts

2026-07-11

Expected to finish

2027-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with pediatric acute leukemia, including acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia.
• Age younger than 18 years at diagnosis.
• Availability of peripheral blood plasma cfDNA/ctDNA testing data.
• Availability of clinical data and at least one corresponding bone marrow-based assessment, including MFC-MRD, ddPCR, RNA sequencing.
• For prospectively collected follow-up data or samples, written informed consent will be obtained from parents or legal guardians.
• For retrospectively collected data, consent procedures will follow the approval of the institutional ethics committee.

You may not qualify if…

• Patients without available peripheral blood plasma cfDNA/ctDNA data.
• Patients with insufficient clinical or laboratory data for analysis.
• Samples failing cfDNA/ctDNA quality control.
• Withdrawal of consent for prospective follow-up or additional sample collection.
• Patients judged by the investigator to be unsuitable for inclusion.

Where it is running

• Department of Pediatric Hematology/Oncology,Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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