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NCT Number: NCT07250217

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Mulhouse, Alsace, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • / 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.

Treatment and study plan

Epigenetic markers

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard DRENOU, Dr

CONTACT

[email protected]

+33389646464

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Collaborators

  • Institut de Recherche en Hématologie et Transplantation (IRHT)

Registry information

Official study title

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

Acronym: LAMME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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