A Multimodal Retrospective Cohort Analysis of Clinical, Laboratory, Neuroimaging, Electroencephalographic, and Biomarker Characteristics in Patients With Creutzfeldt-Jakob Disease: The CLIME-CJD Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of CJD Patients With Characteristic Diagnostic Findings
研究概览
简要总结
Creutzfeldt-Jakob disease (CJD) is a rare and rapidly progressive neurological disorder. This study aims to describe and summarize the key features of CJD by looking back at medical records of patients who were diagnosed with CJD at our hospital. The researchers will collect information from routine clinical evaluations, including patients' symptoms, blood tests, cerebrospinal fluid analysis, brain imaging (such as MRI and PET), and electroencephalography (EEG). By analyzing these data together, the study hopes to provide a clearer picture of how CJD presents in routine clinical practice. This may help doctors recognize the disease more quickly in the future. No new tests or treatments will be given to patients. All data are collected from existing medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of definite or probable Creutzfeldt-Jakob Disease (CJD) according to the established WHO diagnostic criteria
- •Available medical records covering at least one of the following: clinical history, peripheral blood test results, cerebrospinal fluid (CSF) analysis findings, brain MRI reports/images, or EEG reports
- •Hospitalized or evaluated at the participating institution during the study period
排除标准
- •Alternative diagnosis confirmed that explains all clinical features (e.g., autoimmune encephalitis, rapidly progressive dementia due to other causes)
- •Incomplete medical records with no relevant clinical, laboratory, imaging, or EEG data available
- •Patient or legal representative declined the use of medical records for research purposes (where applicable according to local regulations)
结局指标
主要结局
Proportion of CJD Patients With Characteristic Diagnostic Findings
时间窗: Baseline
The primary outcome is the proportion of patients showing characteristic abnormalities across five domains: clinical symptoms, peripheral blood markers, cerebrospinal fluid 14-3-3 protein and RT-QuIC, brain MRI (cortical ribboning or basal ganglia hyperintensity), and EEG (periodic sharp wave complexes).
次要结局
未报告次要终点