Headache registration and follow-up program at Tongji Hospital
Headache Registration and Followup Initiated by Tongji Hospital, HUST
This program will collect clinical records, imaging, questionnaires, and blood samples from people aged 6–70 with diagnosed headaches to build a large database to help develop better diagnosis and treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Ages | 6 Years to 70 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07269561 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective observational cohort led by Tongji Hospital that aims to enroll up to 50,000 participants with clinical data and 1,500 participants who provide biological specimens. Initial data collection includes epidemiological information, clinical assessments, imaging, standardized questionnaires, and a 5 ml venous blood sample, with planned multi-omics and biobanking. Participants will be followed for up to 10 years with face-to-face visits in the first three months and annual telephone follow-ups thereafter to record medication use, clinical outcomes, and adverse events. The project will build integrated clinical and multi-omics databases and apply machine-learning and bioinformatics to identify diagnostic markers, drug targets, and precision treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are people aged 6–70 who meet ICHD-3 headache diagnostic criteria, can give informed consent (or have guardian consent), and can comply with follow-up and questionnaires.
Not a fit: Patients with highly complex headache etiologies (three or more distinct causes), severe systemic disease with life expectancy under ten years, or major cognitive/psychiatric impairments that prevent follow-up are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this program could lead to more accurate diagnoses, personalized treatment approaches, and identification of new biological targets for people with headaches.
How similar studies have performed: While large population headache cohorts and some biomarker studies exist, combining long-term multi-omics biobanking with machine-learning for precision headache diagnosis and treatment is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Wuhan, Hubei
- Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Wensheng Qu Professor, DM PhD
- Email: wsqu@tjh.tjmu.edu.cn
- Phone: +8618971622660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.