Plasma ctDNA Monitoring in Pediatric Acute Leukemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov