Cohort Study of Blood Biomarkers for TES

Completed

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

• 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

Arm && Interventions

Group	Intervention	Description
Athletes with rmTBI history	Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination	50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau
Patients with rmTBI history	Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination	50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital
Healthy volunteer	Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination	20 healthy volunteers

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