NCT07751588Not yet recruiting
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 · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- 11 Jul 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- NCT number
- NCT07751588
What you commit to
- Study type: Observational
- Planned participants: 25
- From 11 Jul 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients with insufficient clinical or laboratory data for analysis.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pediatric Hematology/Oncology,Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.