Cohort Study of Blood Biomarkers for TES

January 8, 2026 updated by: Xintong Ge, Tianjin Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xintong Ge, Doctor
  • Phone Number: 86-022-60364359
  • Email: xge@tmu.edu.cn

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
  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
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
  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
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
  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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline
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
5 years post-enrollment
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
5 years post-enrollment
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 years post-enrollment
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.
5 years post-enrollment
Cognitive function tests - MoCA
Time Frame: 5 years post-enrollment
Montreal cognitive assessment (MoCA). Reference Range: 0-30. Higher scores mean a better outcome.
5 years post-enrollment
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.
5 years post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tianjin Medical University General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ping Lei, Doctor, Tianjin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2021-YX-056-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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