Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 175
- 主要终点
- incidence of disease-related genetic markers
研究概览
简要总结
This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms
Investigator's sites: 80-90 sites in Germany and Austria
Estimated duration of observation of an individual patient:
10 years maximum
Objectives
- To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness)
- To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations)
- To assess patient and family history, as well as patient characteristics
- To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival [EFS], relapse-free survival [RFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
- To evaluate the impact of measurable residual disease (MRD) by different methods
- To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
- To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus Classification
- •Age ≥ 18 years. There is no upper age limit.
- •Signed written informed consent
排除标准
- •Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- •No consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation
- •No consent for biobanking of patient's biological specimens and performance of analyses on stored material.
结局指标
主要结局
incidence of disease-related genetic markers
时间窗: 4 weeks
To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)
Event-free survival
时间窗: 10 years
To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Cumulative incidence of relapse
时间窗: 10 years
To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Cumulative incidence of death
时间窗: 10 years
To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Overall survival
时间窗: 10 years
To assess patient and family history, patient characteristics and outcome data (event-free survival \[EFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\])
Treatment decision (intensive, non-intensive, investigational)
时间窗: 1 year
To perform rapid analyses of disease-related genetic markers (according to ICC 2022) (incidences, treatment recommendations)
quality of life
时间窗: 2 years
Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, socioeconomics, and demographics according to Messerer D et al (2008), 6, 12 and 24 months after registration.
Geographical representation
时间窗: 1 day
Geographical representation of patients through collection of patients zip codes
Response to therapy
时间窗: 1 year
Rate of response: complete remission (CR), CR with partial hematologic recovery (CRh); CR with incomplete hematologic recovery (CRi)
Relapse-free survival
时间窗: 10 years
Measurable residual disease (MRD)
时间窗: 10 years
次要结局
未报告次要终点
研究者
Prof. Dr. Hartmut Doehner
Prof. Dr.
University of Ulm