Clinical trial · Observational
Plasma ctDNA Monitoring in Pediatric Acute Leukemia
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Consistence between peripheral blood plasma ctDNA and bone marrow MFC-MRD
- timeFrame
- From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation.
- description
- Concordance between peripheral blood plasma ctDNA status and matched bone marrow MFC-MRD results.
Secondary outcomes (3)
- measure
- Event-free survival
- timeFrame
- The time from diagnosis to relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 36 months.
- measure
- Overall survival
- timeFrame
- From the date of diagnosis until the date of death from any cause or last follow-up, whichever occurs first, assessed up to 36 months.
- measure
- ctDNA clearance rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available