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

February 3, 2026 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Mulhouse, France, 68100
        • Recruiting
        • GHRMSA
        • Sub-Investigator:
          • Gheorghe Gavra, MD
        • Contact:
    • Alsace
      • Mulhouse, Alsace, France, 68100
        • Recruiting
        • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
        • Contact:
        • Sub-Investigator:
          • Gheorghe Gavra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of methylation of specific CpG sites
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Collaborators

Institut de Recherche en Hématologie et Transplantation (IRHT)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHRMSA 1447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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