Headache Registration and Followup Initiated by Tongji Hospital, HUST
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Development of integrated precision diagnosis and treatment system for headache
研究概览
简要总结
Headache is one of the most common chief complaints in clinical practice, with a high global prevalence rate. It may originate from a primary headache disorder or manifest as a clinical symptom of various diseases due to the complexity of its triggers, specific types, diagnosis, and treatment which present significant challenges. As people's life pace continues to accelerate and psychological and physiological pressures increase, many patients experience headache symptoms, leading to a growing number of patients seeking treatment in neurology departments. The increasing incidence of headache conditions has resulted in a decline in patients' quality of life.
Therefore, this research is part of Hubei Province's major project "Discovery and Functional Research of Major Disease Targets Based on Genetic Big Data." The study aims to establish a clinical cohort and develop a precise diagnosis and treatment system for headaches. This system will collect the history of headache sufferers, record the real-world treatment data, and incorporate sample banks, multi-dimensional databases, pre-clinical drug evaluation platforms, and clinical efficacy precise dynamic monitoring models through immunotherapy and other cutting-edge biotechnologies, multi-omics detection technologies, and big data bioinformatics analysis technologies.
The system will provide scientists and clinicians with auxiliary diagnostic and treatment decision support, offer reliable screening targets for early headache diagnosis and drug development companies, accelerate the latest headache diagnosis and targeted treatment, and achieve breakthrough advances in headache prevention and cure.
详细描述
This research is a multi-center, prospective observational study focusing on headache patients, initiated by Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology (HUST). The study encompasses several key components:
- Study Population and Data Collection:
- Target enrollment: 50,000 with clinical data, and 1,500 headache patients with biological specimen collection
- Recruitment site: Department of Neurology, Tongji Hospital; cooperate headache centers around China
Initial data collection includes:
- Epidemiological information
- Clinical data
- Imaging data
- Questionnaire responses
- 5ml venous blood samples
Follow-up Protocol:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for headache classification according to the International Classification of Headache Disorders 3rd edition (ICHD-3, 2018) Age between 6-70 years Voluntary participation with consent Good compliance with follow-up and questionnaire surveys
排除标准
- •Complex headache etiology, e.g., presence of ≥3 distinct factors causing headache Presence of severe systemic diseases or life expectancy less than 10 years Significant cognitive or psychiatric issues that prevent completion of questionnaire follow-ups and clinical assessments
结局指标
主要结局
Development of integrated precision diagnosis and treatment system for headache
时间窗: 5 years
Establishment and validation of a comprehensive system combining: Clinical database and biological repository real-world treatment and efficiency Multimodal neuroimaging biomarkers (MRI, EEG) Multi-omics data analysis to guide precise diagnosis and personalized treatment decisions.
次要结局
- Brain network characterization and biomarker identification(Baseline and annual follow-up for 5 years)
- Clinical efficacy of treatment approaches(Baseline and annual follow-up for 5 years)
- Novel therapeutic target identification(5 years)