Chronic Traumatic EncephalopathyNCT04928534
Cohort Study of Blood Biomarkers for TES
An observational study of Chronic Traumatic Encephalopathy and Traumatic Encephalopathy, Chronic, run by Tianjin Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Chronic, Traumatic; Encephalopathy, Postcontusional
- What is being tested?
- Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: 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.
- Conditions
- Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Chronic, Traumatic; Encephalopathy, Postcontusional
- Being tested
- Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination
- Medical subject headings
- Chronic Traumatic Encephalopathy, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examinationDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Athletes with rmTBI history | 50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (7)
Blood level of classical biomarkers for CTE/TES
Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay
Measured: Baseline
Ultrasound examination of the carotid arteries and lower limb arteries
Ultrasound examination of bilateral CCA, ICA, CFA, SFA, PA, DPA and ATA
Measured: 5 years post-enrollment
Serum Treg cell count and degree of senescence
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
Measured: 5 years post-enrollment
Cognitive function tests - RPQ-3
Rivermead post-concussion symptoms questionnaire - 3 (RPQ-3). Reference Range: 0-12. Higher scores mean a worse outcome.
Measured: 5 years post-enrollment
Cognitive function tests - RPQ-16
Rivermead post-concussion symptoms questionnaire - 16 (RPQ-16). Reference Range: 0-64. Higher scores mean a worse outcome.
Measured: 5 years post-enrollment
Cognitive function tests - MoCA
Montreal cognitive assessment (MoCA). Reference Range: 0-30. Higher scores mean a better outcome.
Measured: 5 years post-enrollment
Cognitive function tests - MMSE
Description: mini-mental state examination (MMSE). Reference Range: 0-30. Higher scores mean a better outcome.
Measured: 5 years post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 May 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Traumatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Xintong Ge, Tianjin Medical University General Hospital
- Investigators
- Ping Lei, Doctor, Principal investigator, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928534
- Sponsor's protocol ID
- IRB2021-YX-056-01
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Blood Transcriptomics and Proteomics Information as Biomarkers of Traumatic Encephalopathy Syndrome
- ClinicalTrials.gov ID
- NCT04928534
- Acronym / sponsor ID
- IRB2021-YX-056-01
- Conditions
- Chronic Traumatic Encephalopathy, Traumatic Encephalopathy, Chronic, Traumatic; Encephalopathy, Postcontusional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Athletes with rmTBI history | – | 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) examination50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau |
| Patients with rmTBI history | – | 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) examination50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital |
| Healthy volunteer | – | 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) examination20 healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Athletes and patients with traumatic brain injury
- Healthy Volunteers
Key exclusion criteria (12 listed)
- Athletes and patients with traumatic brain injury
- Healthy Volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination1. 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 | Diagnostic test | Athletes with rmTBI history, Healthy volunteer, Patients with rmTBI history |
Primary outcome
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.
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.
7 secondary outcomes
Blood level of classical biomarkers for CTE/TES
Time frame: Baseline
Ultrasound examination of the carotid arteries and lower limb arteries
Time frame: 5 years post-enrollment
Serum Treg cell count and degree of senescence
Time frame: 5 years post-enrollment
Cognitive function tests - RPQ-3
Time frame: 5 years post-enrollment
Cognitive function tests - RPQ-16
Time frame: 5 years post-enrollment
Cognitive function tests - MoCA
Time frame: 5 years post-enrollment
Cognitive function tests - MMSE
Time frame: 5 years post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Lei, Doctor principal investigator
Tianjin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Traumatic Encephalopathy and Traumatic Encephalopathy, Chronic, run by Tianjin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood level of novel protein biomarkers for CTE/TES (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.