NCT04928534

Cohort Study of Blood Biomarkers for TES

Observational Cohort Study of Blood Transcriptomics and Proteomics Information as Biomarkers of Traumatic Encephalopathy Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

In this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential CTE/TES biomarkers (RNA and protein) in blood and its exosomes. Thereafter, these biomarkers will be combined with the reported TBI biomarkers to create a novel set of CTE/TES molecular diagnostic signatures. The findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.

Conditions

• Chronic Traumatic Encephalopathy
• Traumatic Encephalopathy, Chronic
• Traumatic; Encephalopathy, Postcontusional

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination	1. Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181. 2. Cognitive function tests, including RPQ, MMSE and MoCA. 3. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-06-16
• Last updated: 2026-01-12

Locations

1 site across 1 country: China