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Blood tests for tumor DNA in children with acute leukemia

Compares blood tumor DNA results with bone marrow tests in children with leukemia.

Plain-language title generated from the registry record
Registry title: Plasma ctDNA Monitoring in Pediatric Acute Leukemia

Key facts

Where
Tianjin, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with acute leukemia who have a blood plasma ctDNA test and at least one matching bone marrow test result.

Age
Younger than 18 years at diagnosis. The record lists 3 Years to 18 Years.
Sex
All sexes can join.
Disease stage
Acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia.
Biomarker or test result
Blood plasma cfDNA/ctDNA test data must be available. At least one bone marrow test (MFC-MRD, ddPCR or RNA sequencing) must be available.

Main reasons for not taking part

  • No blood plasma cfDNA/ctDNA data
  • Not enough clinical or lab data for analysis
  • Samples that fail cfDNA/ctDNA quality control
  • Consent withdrawn for follow-up or extra samples
  • Judged by the investigator as unable to take part

Read by machine on 11 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 3 and 18 years old?

Source: NCT07751588, who can take part

Where in China

  • Department of Pediatric Hematology/Oncology,Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical SciencesTianjin, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Institute of Hematology & Blood Diseases Hospital, China
Trial code
NCT07751588
Record updated
7 August 2026
Original description
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.Read full original descriptionShow less

A Retrospective-Prospective Observational Cohort Study of Peripheral Blood Plasma ctDNA Compared With Bone Marrow MFC-MRD, ddPCR, and RNA Sequencing in Pediatric Acute Leukemia

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.

Inclusion: 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.

Exclusion: Patients with insufficient clinical or laboratory data for analysis; Patients without available peripheral blood plasma cfDNA/ctDNA data; 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.

ClinicalTrials.gov NCT07751588