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Development of a Digital Molecular Diagnostic Kit for Pediatric Epilepsy Based on High-Performance Liquid Chromatography-Tandem Mass Spectrometry

Development of a Digital Molecular Diagnostic Kit for Pediatric Epilepsy Based on High-Performance Liquid Chromatography-Tandem Mass Spectrometry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120252
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Gold Standard:According to the latest standards of the International League Against Epilepsy (ILAE) in 2017, combined with a detailed clinical history and the results of video electroencephalogram (vE
Index test:Digital Molecular Diagnostic Kit for Children's Epilepsy Based on High Performance Liquid Chromatography-tandem Mass spectrometry (LC-MS/MS) (Purine)

Sponsors

Capital Children's Medical Center, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: Case Group 1. Children with a first-time diagnosis of epilepsy based on the latest 2017 ILAE criteria, combined with detailed clinical history and video EEG (vEEG) findings; 2. Age >=3 years and =3 years and <18 years; 2. No history of clinical seizures and normal EEG findings; 3. Subjects and/or guardians signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of a high-purine diet within the past month (e.g., seafood, animal offal, etc.); 2. Current use of medications known to interfere with purine metabolism; 3. Children with severe physical comorbidities including renal dysfunction, systemic infection, malignant tumor, or immune system disease.

Design outcomes

Primary

MeasureTime frame
Diagnostic performance of the five-indicator combined model in distinguishing epileptic children from healthy controls (AUC, sensitivity, specificity, positive predictive value, negative predictive value, accuracy);Optimal clinical decision threshold (Cut-off) of the diagnostic model;

Countries

China

Contacts

Public ContactChen Qian

Capital Children's Medical Center, Capital Medical University

dr_chenqian@163.com+86 10 8569 5639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026