NCT07751588

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 11, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 7, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 21, 2026

Last Update Submit

August 5, 2026

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Consistence between peripheral blood plasma ctDNA and bone marrow MFC-MRD

    Concordance between peripheral blood plasma ctDNA status and matched bone marrow MFC-MRD results.

    From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation.

Secondary Outcomes (3)

  • Event-free survival

    The time from diagnosis to relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 36 months.

  • Overall survival

    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.

  • ctDNA clearance rate

    From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation.

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children were diagnosised with ALL.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Hematology/Oncology,Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow, Peripheral blood

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Xiaofan Zhu, MD

    Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lipeng Liu, MD

CONTACT

86-22-23909336liulipeng@ihcams.ac.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

August 7, 2026

Study Start

July 11, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 7, 2026

Record last verified: 2026-07

Locations

CN(1)