Acute Myeloblastic Leukemia
Conditions
Keywords
Acute Myeloblastic Leukemia, Methylome, Epigenetic markers, Bone marrow, Diagnosis
Brief summary
The main objective of this study is to identify epigenetic markers specific to abnormal myeloid cells in patients with acute myeloid leukemia (AML) by analyzing the methylation of circulating cell-free DNA in plasma.
Detailed description
Secondary objectives: * To evaluate the correlation between epigenetic markers and clinical response to treatment with Azacytidine. * To compare methylation patterns between patients who respond and those who do not respond to treatment of AML. Conduct of research: This study will allow the collection of samples for the establishment of a biobank. The study population is divided into two groups: Control group: Elderly patients scheduled for thoracic surgery involving sternotomy. A bone marrow sample (2 mL) will be obtained by sternal puncture in the operating room (after general anesthesia and before sternotomy), and an additional blood sample (10 mL) will be collected during the hospital stay. AML group: Elderly patients diagnosed with acute myeloid leukemia. An additional volume of blood (10 mL) and bone marrow (2 mL) will be collected during follow-up visits as part of their routine care.
Interventions
DIAGNOSTIC_TESTEpigenetic markers
Methylation profiles will be analyzed and DNA regions (CpG sites) that show significant differences between healthy and pathological cells from bone marrow will be identified. These regions could serve as epigenetic markers for cells from patients with LAM, if they can be used by digital PCR. These differentially methylated CpG islands will be targeted for the design of specific primer and probe pairs for use in digital PCR. The markers will then be tested in circulating free DNA from blood.
Sponsors
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Institut de Recherche en Hématologie et Transplantation (IRHT)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. / Control Group Inclusion Criteria: * Age ≥ 60 years; * Scheduled for cardiac surgery involving sternotomy; * Normal blood count within the two months preceding sampling; * Affiliated with, or beneficiary of, a social security system; * Written informed consent to participate in the study.
Exclusion criteria
* Patients deemed unsuitable for sampling by the surgeon performing the procedure; * Patients under legal protection measures; * Patients under judicial supervision or deprived of liberty by judicial or administrative decision; * Presence of positive virological markers indicating active infection (hepatitis B, hepatitis C, or HIV). 2. / AML Group Inclusion Criteria: * Age ≥ 60 years; * Diagnosis of de novo AML or AML secondary to myelodysplastic syndrome, scheduled to receive azacitidine-based treatment; * Affiliated with, or beneficiary of, a social security system; * Written informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of methylation of specific CpG sites | Baseline | The methylation of circulating free DNA in plasma is quantified by measuring the percentage of methylation of specific CpG motifs analyzed in cfDNA relative to total methylation. |
Countries
France
Contacts
CONTACTBernard DRENOU, Dr
Outcome results
None listed