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A simple blood draw could spare kids with leukemia from painful bone marrow tests

NCT ID NCT07751588

Knowledge-focused Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study looks at whether a blood test that detects tumor DNA (ctDNA) can give the same information as bone marrow tests in children with acute leukemia. Researchers will compare ctDNA results with standard bone marrow checks for minimal residual disease. The goal is to see if blood tests could monitor the disease and predict relapse or survival, potentially reducing the need for invasive procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peripheral blood plasma circulating tumor DNA (ctDNA) testing
What this could lead to
If blood-based ctDNA tests match bone marrow results, children with leukemia could be monitored with a simple blood draw instead of repeated bone marrow biopsies.
What could go wrong
This is a small observational study, so results may not apply to all patients. ctDNA might not always reflect bone marrow findings, and the study does not test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children were diagnosised with ALL.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia mixed phenotype acute leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Tianjin, Tianjin Municipality, 300020, China

More trials for these conditions

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