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Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07250217•Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

View on ClinicalTrials.gov

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. / Control Group
•* 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);
+2 more criteria

Locations (2)

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Mulhouse, Alsace, France

GHRMSA

Mulhouse, France

Key Dates

Start Date

January 13, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

February 4, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloblastic Leukemia

Interventions

Epigenetic markers

DIAGNOSTIC_TEST

Contacts

Bernard DRENOU, Dr

CONTACT

+33389646464 drenoub@ghrmsa.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients

Inclusion Criteria

Exclusion Criteria

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