Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epigenetic markers.
- Who it may be relevant to
- Registry conditions: Acute Myeloblastic Leukemia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collection of Biological Samples for Research Purposes: Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
Overview
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 test Epigenetic 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.
Primary outcome measures
- Percentage of methylation of specific CpG sites [Time frame: Baseline]
Eligibility criteria
- / 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).
- / 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.
Exclusion criteria
- Diagnosis of a hematologic disease other than AML;
- Clinical signs suggestive of active central nervous system leukemia, or presence of isolated extramedullary leukemia;
- Previous treatment for AML other than hydroxyurea;
- Severe comorbidities that could interfere with the study, as assessed by the principal investigator;
- Presence of positive virological markers indicating active infection (hepatitis B, hepatitis C, or HIV);
- Patients under legal protection;
- Patients under judicial supervision or deprived of liberty by judicial or administrative decision.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- Groupe Hospitalier de la Région de Mulhouse et Sud Alsace — Mulhouse
- GHRMSA — Mulhouse
Identifiers
NCT: NCT07250217 · GHRMSA 1447