Trial Title:
Study of the Medullary Microenvironment in Acute Childhood Leukemia
NCT ID:
NCT05792007
Condition:
Acute Lymphoid Leukemia
Acute Myeloid Leukemia in Children
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Open-label, interventional monocentric biological study in two parallel and controlled
groups
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biological sampling in patients
Description:
blood and bone marrow samples from patients with Acute Leulemia.
Arm group label:
Patients with acute leukemias
Intervention type:
Procedure
Intervention name:
Biological sampling in control patients
Description:
blood and bone marrow samples from children undergoing orthopedic surgery exposing the
bone marrow.(osteotomy of the pelvis).
Arm group label:
Control group
Summary:
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of
chemotherapy treatments and the development of supportive care, a certain number of LAs
relapse and/or progress to death of the child. It therefore seems essential to try to
better understand the physiopathology and the mechanisms of resistance to treatment of
these diseases.
Detailed description:
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of
chemotherapy treatments and the development of supportive care, a certain number of AL's
relapse and/or progress to death of the child. It therefore seems essential to try to
better understand the physiopathology and the mechanisms of resistance to treatment of
these diseases. The study of the microenvironment appears in this context as a promising
avenue. The bone marrow microenvironment is composed of an extracellular matrix and
cells, in particular mesenchymal stromal stem cells (MSC's). In adult acute leukemia, it
has been clearly demonstrated that these microenvironment cells are reprogrammed by
leukemia cells to allow the development and proliferation of the latter. Links have also
been demonstrated in acute leukemia between the cells of the microenvironment and
resistance to chemotherapy. In a certain number of cases, the support of the
microenvironment for the development of leukemia or resistance to chemotherapy involves
modulation of the energy metabolism of leukemia cells. This notably involves interactions
between leukemic cells and MSCs and re-programming of the energy metabolism of the
latter. To date, there are only very few studies concerning the role of the
microenvironment in acute childhood leukemia and none to date has specifically studied
the energy metabolism (oxidative phosphorylation and glycolysis) of MSCs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- for patients with AL:
1. Child with acute lymphoblastic or myeloblastic leukemia at diagnosis
2. Not having received prior hematological treatment
3. Aged 1 to 15 years old
4. Whose 2 parents, or the holder of parental authority, have signed a consent
enlightened.
5. Affiliated patient or beneficiary of a social security scheme.
- Control group patients:
1. Child undergoing orthopedic surgery exposing the bone marrow (osteotomy of the
pelvis).
2. Aged between 1 and 15 years old.
3. Having no pathology of hematological origin.
4. Not having received any treatment that could interfere with the functioning of
the bone marrow.
5. Whose 2 parents or the holder of parental authority have signed a consent
enlightened.
6. Affiliated patient or beneficiary of a social security scheme.
Exclusion Criteria:
- for patients with AL:
1. Patient under 1 year old and over 15 years old.
2. Contraindication to myelogram.
3. Absence of signature of the informed consent by the 2 parents or the holder of
parental authority.
4. Patients with relapsed acute lymphoblastic or myeloblastic leukemia.
5. Having received prior hematological treatments.
6. Parents with physical or mental condition not allowing to understand the
informed consent.
- Control group patients
1. Patient under 1 year old and over 15 years old.
2. Having an underlying haematological pathology.
3. Absence of signature of the informed consent by the 2 parents or the holder of
parental authority.
4. Having received prior hematological treatments.
5. Parents with physical or mental condition not allowing to understand informed
consent.
Gender:
All
Minimum age:
1 Year
Maximum age:
15 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Service d'hématologie biologique-CHRU TOURS
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier HERAULT, MD-PhD
Phone:
+33(0)247474721
Email:
olivier.herault@univ-tours.fr
Investigator:
Last name:
Olivier HERAULT, MD-PhD
Email:
Principal Investigator
Facility:
Name:
Service d'onco-hématologie pédiatrique -CHRU Tours
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Recruiting
Contact:
Last name:
Julien LEJEUNE, MD-PhD
Email:
j.lejeune@chu-tours.fr
Investigator:
Last name:
Julien LEJEUNE, MD-PhD
Email:
Principal Investigator
Investigator:
Last name:
Emmanuel Gyan, MD-PhD
Email:
Sub-Investigator
Investigator:
Last name:
Pascale Blouin, MD
Email:
Sub-Investigator
Investigator:
Last name:
Anne Jourdain, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marion Gillibert-Yvert, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jill Serre, MD
Email:
Sub-Investigator
Investigator:
Last name:
Léa Bosdure, MD
Email:
Sub-Investigator
Facility:
Name:
Service de chirurgie orthopédique pédiatrique -CHRU TOURS
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Recruiting
Contact:
Last name:
Thierry ODENT, MD-PhD
Phone:
+33(0)247473822
Email:
t.odent@chu-tours.fr
Investigator:
Last name:
Thierry ODENT, MD-PhD
Email:
Principal Investigator
Start date:
October 26, 2023
Completion date:
October 24, 2028
Lead sponsor:
Agency:
University Hospital, Tours
Agency class:
Other
Source:
University Hospital, Tours
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792007
