Actively Recruiting

Phase Not Applicable
Age: 1Year - 15Years
All Genders
Healthy Volunteers
ID05792007

Study of the Medullary Microenvironment in Childhood Acute Leukemias

Led by University Hospital, Tours · Updated on 2025-11-24

40

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute leukemia is the most common cancer in children and can sometimes relapse or lead to death despite improvements in chemotherapy and supportive care. This research focuses on better understanding the disease's biology, especially how the bone marrow environment affects leukemia cells and their resistance to treatment. The study highlights the importance of the bone marrow microenvironment, including mesenchymal stromal stem cells, and their role in leukemia growth and chemotherapy resistance in children. The study involves two groups: children diagnosed with acute lymphoid leukemia B or T, or acute myeloid leukemia, and a control group of children without blood diseases undergoing orthopedic surgery exposing bone marrow. Researchers will collect blood and bone marrow samples from both groups to study the energy metabolism and other cellular characteristics of mesenchymal stromal stem cells. The study is non-randomized and does not involve masking or blinding. Participants will have biological samples taken at inclusion, which will be analyzed for oxygen consumption rate and other measures such as acidification rate, reactive oxygen species, cell doubling time, immunophenotypic profiles, mutational profiles, transcriptomic signatures, and cytokine profiles within the bone marrow. The study will monitor these outcomes to better understand how the bone marrow environment influences acute childhood leukemia. Participation requires parental consent and social security affiliation, with a total age range of 1 to 15 years old.

CONDITIONS

Brief Title

Study of the Medullary Microenvironment in Acute Childhood Leukemia

Who Can Participate

Age: 1Year - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child with acute lymphoblastic or myeloblastic leukemia at diagnosis
  • No prior hematological treatment received
  • Age between 1 and 15 years old
  • Both parents or legal guardians have signed informed consent
  • Affiliated with a social security scheme
  • Child undergoing orthopedic surgery exposing bone marrow (osteotomy of the pelvis) for control group
  • No hematological disease for control group
  • No treatment interfering with bone marrow function for control group
  • Both parents or legal guardians have signed informed consent for control group
  • Affiliated with a social security scheme for control group
Not Eligible

You will not qualify if you...

  • Age under 1 year or over 15 years old
  • Contraindication to myelogram
  • Lack of informed consent signed by both parents or legal guardians
  • Relapsed acute lymphoblastic or myeloblastic leukemia
  • Prior hematological treatment received
  • Parents with physical or mental condition preventing understanding of informed consent
  • Underlying hematological pathology for control group
  • Prior hematological treatment received for control group

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion

Participants undergo biological sampling including blood and bone marrow samples to study the microenvironment and energy metabolism in childhood acute leukemias or control conditions.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion

Participants are observed after the diagnostic evaluation to understand the physiopathology and mechanisms of resistance in childhood acute leukemias.

Visits as needed per clinical follow-up

Trial Site Locations

Total: 3 locations

1

Service d'hématologie biologique-CHRU TOURS

Tours, France, 37044

Not Yet Recruiting

2

Service d'onco-hématologie pédiatrique -CHRU Tours

Tours, France, 37044

Actively Recruiting

3

Service de chirurgie orthopédique pédiatrique -CHRU TOURS

Tours, France, 37044

Actively Recruiting

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Research Team

O

Olivier HERAULT, MD-PhD

W

Wiebe de JONG, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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