Acute Myeloid LeukemiaNCT07751588
Plasma ctDNA Monitoring in Pediatric Acute Leukemia
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children were diagnosised with ALL.
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients judged by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Pediatric Hematology/Oncology,Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lipeng Liu, MD, +86 22 2390919, liulipeng@ihcams.ac.cn
About this study
Official title: 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
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.
Read the detailed description
Minimal residual disease assessment is essential for treatment response evaluation and risk stratification in pediatric acute leukemia. Conventional MRD monitoring mainly relies on bone marrow-based assays, including multiparameter flow cytometry, molecular assays, and sequencing-based methods. However, repeated bone marrow sampling is invasive, and peripheral blood plasma ctDNA may provide a minimally invasive approach for dynamic disease monitoring.
This study will include pediatric patients with acute leukemia who have available peripheral blood plasma ctDNA testing data and corresponding clinical or molecular information. Existing clinical records, laboratory results, leukemia-related genetic findings, bone marrow MFC-MRD results, ddPCR results, RNA sequencing results, treatment information, and follow-up outcomes will be retrospectively collected. After study registration, follow-up outcomes and additional serial molecular monitoring data will be prospectively collected when available.
Peripheral blood plasma cfDNA/ctDNA results will be compared with matched or corresponding bone marrow-based assessments, including MFC-MRD, ddPCR, and RNA sequencing. The study will evaluate the concordance between plasma ctDNA and conventional bone marrow-based assays at different treatment time points, including diagnosis, pre-transplantation, post-transplantation, follow-up, and suspected relapse when available.
The study will further assess ctDNA clearance, persistence, or re-emergence during treatment and follow-up. Exploratory analyses will evaluate whether ctDNA dynamics are associated with treatment response, relapse, event-free survival, relapse-free survival, and overall survival.
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: The time from diagnosis to relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 36 months.
Overall survival
Measured: 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
The rate of change of ctDNA positive to negative after stem cell transplantation.
Measured: From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start11 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaofan Zhu, MD, Principal investigator, Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751588
- Sponsor's protocol ID
- IIT2026086
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07751588
- Acronym / sponsor ID
- IIT2026086
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 11 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Minimal residual disease assessment is essential for treatment response evaluation and risk stratification in pediatric acute leukemia. Conventional MRD monitoring mainly relies on bone marrow-based assays, including multiparameter flow cytometry, molecular assays, and sequencing-based methods. However, repeated bone marrow sampling is invasive, and peripheral blood plasma ctDNA may provide a minimally invasive approach for dynamic disease monitoring.
This study will include pediatric patients with acute leukemia who have available peripheral blood plasma ctDNA testing data and corresponding clinical or molecular information. Existing clinical records, laboratory results, leukemia-related genetic findings, bone marrow MFC-MRD results, ddPCR results, RNA sequencing results, treatment information, and follow-up outcomes will be retrospectively collected. After study registration, follow-up outcomes and additional serial molecular monitoring data will be prospectively collected when available.
Peripheral blood plasma cfDNA/ctDNA results will be compared with matched or corresponding bone marrow-based assessments, including MFC-MRD, ddPCR, and RNA sequencing. The study will evaluate the concordance between plasma ctDNA and conventional bone marrow-based assays at different treatment time points, including diagnosis, pre-transplantation, post-transplantation, follow-up, and suspected relapse when available.
The study will further assess ctDNA clearance, persistence, or re-emergence during treatment and follow-up. Exploratory analyses will evaluate whether ctDNA dynamics are associated with treatment response, relapse, event-free survival, relapse-free survival, and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children were diagnosised with ALL.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Patients judged by the investigator to be unsuitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Concordance between peripheral blood plasma ctDNA status and matched bone marrow MFC-MRD results.
3 secondary outcomes
Event-free survival
Time frame: The time from diagnosis to relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 36 months.
Overall survival
Time frame: 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
Time frame: From the date of enrollment to 6 months after hematopoietic stem cell transplantation, assessed up to 6 months post-transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaofan Zhu, MD principal investigator
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lipeng Liu, MD (86-22-23909336, liulipeng@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.