DRKS00031604招募中不适用
Characterization, long-term outcome, mechanisms, and treatment of CAR-T cell therapy-associated neurotoxicity - COHERENCY
Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie0 个研究点目标入组 200 人开始时间: 2023年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •informed written consent
- •- Patient is capable of giving consent (capable of understanding the nature and expected benefits and risks of the proposed investigations)
- •- Minimum 18 years of age
- •- sufficient health insurance coverage
- •- Karnofsky Index =70%
- •- The participant belongs to one of the following groups:
- •# Patients/ patients with underlying hemato-oncologic disease for whom CAR T-cell therapy is planned.
- •# Patients with malignant hemato-oncological disease (preferably lymphoma, leukemia, multiple myeloma)
- •# healthy volunteers
- •# Patients with suspected CNS infection undergoing diagnostic lumbar puncture
- •# Patients with suspected or confirmed autoimmunological CNS disease undergoing diagnostic lumbar puncture.
- •- For cohorts 1-3: fluent in written and spoken German language
排除标准
- •- The patient is not willing to consent to the storage, processing and disclosure of pseudonymized medical data for study purposes
- •- The patient is under legal care or lawfully placed in an official institution
- •- To be applied for cohort 1-3 only:
- •# The patient has pre-existing (dementia, identifiable by a MOCA score of <15/30 pts.)
- •# The patient has a history of florid alcohol and/or drug abuse.
- •# The patient is currently suffering from a moderately depressive episode (recognizable by a BDI-FS score of =4 pts.)
- •# The patient has a pacemaker or a non-MRI capable implant.
研究者
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