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Completed

NCT Number: NCT04928534

Cohort Study of Blood Biomarkers for TES

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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
  • 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.
  • Cognitive function tests, including RPQ, MMSE and MoCA.
  • Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination

Primary outcomes

  1. Blood level of novel protein biomarkers for CTE/TES

    Time frame: 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.

  2. Blood level of novel RNA biomarkers for CTE/TES

    Time frame: 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 outcomes

  1. Blood level of classical biomarkers for CTE/TES

    Time frame: Baseline

    Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay

  2. Ultrasound examination of the carotid arteries and lower limb arteries

    Time frame: 5 years post-enrollment

    Ultrasound examination of bilateral CCA, ICA, CFA, SFA, PA, DPA and ATA

  3. Serum Treg cell count and degree of senescence

    Time frame: 5 years post-enrollment

    Percentage of serum regulatory T (Treg) cells relative to the total T cell count; Percentage of senescent Treg cells relative to the total Treg cell count

  4. Cognitive function tests - RPQ-3

    Time frame: 5 years post-enrollment

    Rivermead post-concussion symptoms questionnaire - 3 (RPQ-3). Reference Range: 0-12. Higher scores mean a worse outcome.

  5. Cognitive function tests - RPQ-16

    Time frame: 5 years post-enrollment

    Rivermead post-concussion symptoms questionnaire - 16 (RPQ-16). Reference Range: 0-64. Higher scores mean a worse outcome.

  6. Cognitive function tests - MoCA

    Time frame: 5 years post-enrollment

    Montreal cognitive assessment (MoCA). Reference Range: 0-30. Higher scores mean a better outcome.

  7. Cognitive function tests - MMSE

    Time frame: 5 years post-enrollment

    Description: mini-mental state examination (MMSE). Reference Range: 0-30. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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