German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,172
- 试验地点
- 30
- 主要终点
- Overall survival
研究概览
简要总结
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
详细描述
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
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
- •Both female and male patients meeting the mentioned inclusion criteria will be included in this registry, because the risk to get a myeloid neoplasm does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the registry:
- •Patients with BCR-ABL 1-myeloid neoplasia according to WHO classification or IWG MRI criteria
- •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 handling of the personal data
结局指标
主要结局
Overall survival
时间窗: 25 years
Survival over the whole study duration
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
时间窗: 25 years
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
Treatment decision
时间窗: 25 years
Treatment decision (watch and wait, standard, investigational)
Response
时间窗: 25 years
Response of treatment
Duration of response
时间窗: 25 years
Duration of response over the whole study duration
Progression-free-survival
时间窗: 25 years
Survival without any progression
次要结局
未报告次要终点
研究者
Frank Stegelmann
Principal Investigator Dr. med.
University of Ulm