Epigenetic markers of acute myeloblastic leukemia in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will collect plasma cell-free DNA and small bone marrow samples from two groups: elderly patients with AML scheduled for azacitidine treatment and elderly control patients undergoing sternotomy. Samples (10 mL blood, 2 mL bone marrow) will be obtained during routine care or surgery and stored in a biobank. Genome-wide methylation (methylome) analysis will be used to find epigenetic markers specific to abnormal myeloid cells and to compare patterns between responders and nonresponders to azacitidine. Findings will be correlated with clinical response to explore blood-based markers for diagnosis and treatment monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
  Mulhouse, Alsace, France Recruiting
• Ghrmsa
  Mulhouse, France Recruiting

Study contacts

• Study coordinator: Bernard DRENOU, Dr
• Email: drenoub@ghrmsa.fr
• Phone: +33389646464

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.