Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated With Targeted Therapy: the Model of Chronic Myeloid Leukemia Treated With Tyrosine Kinase Inhibitors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 321
- 试验地点
- 17
- 主要终点
- Biological age determination
研究概览
简要总结
French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by DNA methylation analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •CML in chronic phase at time of diagnosis. Diagnosis must be made no more than 3 months (90 days) prior to inclusion. Diagnosis of chronic-phase CML (European Leukemia Network [ELN] 2020 criteria; Baccarani et al 2013) with confirmation of a Philadelphia chromosome (Ph1). A cryptic Ph1 chromosome must be confirmed by FISH.Criteria must meet the definition of chronic phase CML
- •BCR ::ABL1 transcript quantifiable by quantitative PCR
- •1st-line treatment with tyrosine kinase inhibitor
- •No tyrosine kinase inhibitor or hydroxyurea treatment received prior to first blood sampling (at diagnosis)
- •Signature of informed consent for CML Observatory and signature of informed consent for BIO-TIMER protocol
- •Read and understand French
- •Enrolled in a social security plan or beneficiary of such a plan
排除标准
- •CML in accelerated or blast phase
- •Refusal to participate in the study
- •Treatment started prior to inclusion
- •Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice
- •Pregnant or breast-feeding women
研究组 & 干预措施
All patients
干预措施: Blood and bone marrow sample (Biological)
结局指标
主要结局
Biological age determination
时间窗: Day 0;Month 3;Month 12
The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage.
Individual fragility assessment
时间窗: Day 0;Month 6;Month 12;Month 24;Month 36
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)
Tolerance of tyrosine kinase inhibitors
时间窗: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance assessed by a description of treatment sequences
次要结局
- Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis.(Day 0)
- Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis.(Day 0)
- Evaluation of therapeutic response through quantification of the BCR::ABL transcript(Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36)
- Assessment of patients' quality of life(Day 0;Month 6;Month 12;Month 24;Month 36)
- Assessment of therapeutic response by quantification of residual disease(Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36)