Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients (LAMME)

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status: Enrolling

Conditions: Acute Myeloblastic Leukemia

Treatments: Diagnostic Test: Epigenetic markers

Study type: Interventional

Funder types: Other

Identifiers

NCT07250217

GHRMSA 1447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

AML

Other group

Description:

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.

Treatment:

Diagnostic Test: Epigenetic markers

Control group

Other group

Description:

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.

Treatment:

Diagnostic Test: Epigenetic markers