NCT07250217

Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients

Collection of Biological Samples for Research Purposes: Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Myeloblastic Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-13
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-11-26
• Last updated: 2026-02-04

Locations

2 sites across 1 country: France