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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Athletes with rmTBI history | 50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau |
| |
| 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 |
| |
| Healthy volunteer | 20 healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood level of classical biomarkers for CTE/TES | 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 |
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Inclusion Criteria:
Athletes and patients with traumatic brain injury
Healthy Volunteers
Exclusion Criteria:
Athletes and patients with traumatic brain injury
Healthy Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Ping Lei, Doctor | Tianjin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2021 | Jun 18, 2021 |
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Ultrasound examination of bilateral CCA, ICA, CFA, SFA, PA, DPA and ATA
| 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 | 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. | 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. | 5 years post-enrollment |
| Cognitive function tests - MoCA | Montreal cognitive assessment (MoCA). Reference Range: 0-30. Higher scores mean a better outcome. | 5 years post-enrollment |
| Cognitive function tests - MMSE | Description: mini-mental state examination (MMSE). Reference Range: 0-30. Higher scores mean a better outcome. | 5 years post-enrollment |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2021 | Jun 18, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000070627 | Chronic Traumatic Encephalopathy |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020208 | Brain Injury, Chronic |
| D019636 | Neurodegenerative Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D001925 | Brain Damage, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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