Cohort Study of Blood Biomarkers for TES

NCT04928534 | Completed DMC

• 1 other identifier: IRB2021-YX-056-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Blood level of novel protein biomarkers for CTE/TES

  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.

  Baseline

• Blood level of novel RNA biomarkers for CTE/TES

  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.

  Baseline

Secondary Outcomes (7)

• Blood level of classical biomarkers for CTE/TES

  Baseline

• Ultrasound examination of the carotid arteries and lower limb arteries

  5 years post-enrollment

• Serum Treg cell count and degree of senescence

  5 years post-enrollment

• Cognitive function tests - RPQ-3

  5 years post-enrollment

• Cognitive function tests - RPQ-16

  5 years post-enrollment

Study Arms (3)

Athletes with rmTBI history

50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau

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

Patients with rmTBI history

50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital

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

Healthy volunteer

20 healthy volunteers

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

Interventions

Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination DIAGNOSTIC_TEST

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

Athletes with rmTBI history; Healthy volunteer; Patients with rmTBI history

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Athletes with rmTBI history. The subjects are active or retired athletes who have engaged in weightlifting, wrestling, judo, boxing or taekwondo. All of them have a clear history of rmTBI. * Patients with rmTBI history. The subjects have a history of multiple (≥2 times) exposure to brain trauma, and medical records in Tianjin Medical Insurance designated hospitals. * Healthy volunteers, without rmTBI history.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University: lead
• Tianjin Medical University General Hospital: collaborator

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Chronic Traumatic Encephalopathy; Brain Diseases

Interventions

Hematologic Tests; Physical Examination

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Central Nervous System Diseases; Nervous System Diseases; Brain Injury, Chronic; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ping Lei, Doctor

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 16, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)