Collection of Biological Samples for Research Purposes: Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of methylation of specific CpG sites
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •/ 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.
排除标准
- •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.
研究组 & 干预措施
AML
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.
干预措施: Epigenetic markers (Diagnostic Test)
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.
干预措施: Epigenetic markers (Diagnostic Test)
结局指标
主要结局
Percentage of methylation of specific CpG sites
时间窗: 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.
次要结局
未报告次要终点