Plasma ctDNA Monitoring in Pediatric Acute Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07751588
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Aug 7, 2026
Start date
Jul 11, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)

Primary Outcome Measure

Consistence between peripheral blood plasma ctDNA and bone marrow MFC-MRD [ Time Frame: From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation. ]

Central Contacts

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