CLIME-CJD: A Multimodal Study
2026年5月14日 更新者：First Affiliated Hospital of Fujian Medical University
A Multimodal Retrospective Cohort Analysis of Clinical, Laboratory, Neuroimaging, Electroencephalographic, and Biomarker Characteristics in Patients With Creutzfeldt-Jakob Disease: The CLIME-CJD Study
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.
研究概览
研究类型
观察性的
注册 (估计的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Fuzhou、中国
- The First Affiliated Hospital of Fujian Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不适用
取样方法
非概率样本
研究人群
This study population consists of patients who were diagnosed with Creutzfeldt-Jakob Disease (CJD) at the First Affiliated Hospital of Fujian Medical University between Jan 01, 2022 and Dec 31, 2031.
Potential participants were identified through a search of the hospital's electronic medical record system using diagnostic codes for CJD and related prion diseases.
All patients who met the inclusion and exclusion criteria and had sufficient medical record data available for abstraction were included in the analysis.
No additional recruitment or active enrollment was performed, as this was a retrospective chart review study.
The study population is expected to reflect the typical clinical presentation and diagnostic workup of CJD in a real-world hospital setting.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of CJD Patients With Characteristic Diagnostic Findings
大体时间：Baseline
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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).
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年1月1日
初级完成 (估计的)
2031年12月1日
研究完成 (估计的)
2031年12月1日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年5月14日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月14日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.