Epigenetic markers of acute myeloblastic leukemia in older adults
Collection of Biological Samples for Research Purposes: Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
This project will test whether DNA methylation patterns in blood and bone marrow can identify abnormal AML cells and relate to response in people aged 60 and older treated with azacitidine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Academic / other |
| Locations | 2 sites (Mulhouse, Alsace and 1 other locations) |
| Trial ID | NCT07250217 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with newly diagnosed or secondary AML scheduled for azacitidine-based therapy, and elderly control patients undergoing sternotomy with normal blood counts who consent to sampling.
Not a fit: Patients younger than 60, those not receiving azacitidine, and individuals with active viral infections (hepatitis B, hepatitis C, HIV) or under legal protection measures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could enable less invasive blood-based detection of AML cells and help predict which older patients will respond to azacitidine.
How similar studies have performed: Prior work has shown that methylation patterns in cell-free DNA can detect and track myeloid malignancies, but using these signatures to predict azacitidine response is still relatively novel and under validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mulhouse, Alsace and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.