NCT07250217

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

November 14, 2025

Last Update Submit

February 3, 2026

Conditions

Acute Myeloblastic Leukemia

Keywords

Acute Myeloblastic LeukemiaMethylomeEpigenetic markersBone marrowDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of methylation of specific CpG sites

    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

Study Arms (2)

AML

OTHER

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

Control group

OTHER

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

Interventions

Epigenetic markersDIAGNOSTIC_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.

AMLControl group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Mulhouse, Alsace, 68100, France

RECRUITING

GHRMSA

Mulhouse, 68100, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteDisease

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Bernard DRENOU, Dr

CONTACT

+33389646464drenoub@ghrmsa.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 26, 2025

Study Start

January 13, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)