Cohort Study of Blood Biomarkers for TES

Completed

• Conditions: Chronic Traumatic Encephalopathy; Traumatic Encephalopathy, Chronic; Traumatic; Encephalopathy, Postcontusional

• Registration Number: NCT04928534
• Lead Sponsor: Tianjin Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Athletes and patients with traumatic brain injury

   • Age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative.
   • Have a clear history of repetitive mild TBI, concussion or subconcussion.
   • The most recent head injury occurred 3 months ago.

2. Healthy Volunteers

   • Age ≥ 18 and ≤ 80 years old with independent behavior ability.
   • No history of repetitive mild TBI, concussion or subconcussion.
   • Fully understands the nature of the study, and voluntarily participates and signs the informed consent.

Exclusion Criteria

1. Athletes and patients with traumatic brain injury

   • Pregnant or lactating women.
   • History of other neurological diseases.
   • History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
   • Have participated in clinical trials in the past four weeks.
   • The investigator believes that not appropriate for inclusion.

2. Healthy Volunteers

   • Pregnant or lactating women.
   • History of TBI or other neurological diseases.
   • History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
   • Have participated in clinical trials in the past four weeks.
   • The investigator believe that not appropriate for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood level of novel protein biomarkers for CTE/TES	Baseline	Novel protein biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using ELISA assay.
Blood level of novel RNA biomarkers for CTE/TES	Baseline	Novel RNA biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using RT-PCR.

Secondary Outcome Measures

Name	Time	Method
Blood level of classical biomarkers for CTE/TES	Baseline	Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China