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临床试验/NCT03125707
NCT03125707招募中不适用

German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)

University of Ulm30 个研究点 分布在 1 个国家目标入组 2,172 人开始时间: 2013年5月最近更新:
适应症

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

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

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Stegelmann

Principal Investigator Dr. med.

University of Ulm

研究点 (30)

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