Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients

NCT ID: NCT07250217

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

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.

Conditions

Acute Myeloblastic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AML

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.

Group Type: OTHER

Epigenetic markers

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: OTHER

Epigenetic markers

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• 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

• 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

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Recherche en Hématologie et Transplantation (IRHT)

UNKNOWN

Sponsor Role: collaborator

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GHRMSA

Mulhouse, , France

Countries

France

Central Contacts

Bernard DRENOU, Dr

Role: CONTACT

drenoub@ghrmsa.fr

+33389646464

Facility Contacts

Bernard DRENOU

Role: primary

drenoub@ghrmsa.fr

+33389646464

Other Identifiers

GHRMSA 1447

Identifier Type: -

Identifier Source: org_study_id