Cohort Study of Blood Biomarkers for TES
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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
|
| 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
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
|
| 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
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
|
Outcome Measures
Primary Outcome Measures
- Blood level of novel protein biomarkers for CTE/TES [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 [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 Outcome Measures
- Blood level of classical biomarkers for CTE/TES [Baseline]
Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay
Eligibility Criteria
Criteria
Inclusion Criteria:
- Athletes and patients with traumatic brain injury
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Age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative.
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Have a clear history of repetitive mild TBI, concussion or subconcussion.
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The most recent head injury occurred 3 months ago.
- Healthy Volunteers
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Age ≥ 18 and ≤ 80 years old with independent behavior ability.
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No history of repetitive mild TBI, concussion or subconcussion.
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Fully understands the nature of the study, and voluntarily participates and signs the informed consent.
Exclusion Criteria:
- Athletes and patients with traumatic brain injury
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Pregnant or lactating women.
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History of other neurological diseases.
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History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
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Have participated in clinical trials in the past four weeks.
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The investigator believes that not appropriate for inclusion.
- Healthy Volunteers
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Pregnant or lactating women.
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History of TBI or other neurological diseases.
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History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
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Have participated in clinical trials in the past four weeks.
-
The investigator believe that not appropriate for inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin Medical University General Hospital | Tianjin | Tianjin | China | 300052 |
Sponsors and Collaborators
- Tianjin Medical University
- Tianjin Medical University General Hospital
Investigators
- Principal Investigator: Ping Lei, Doctor, Tianjin Medical University
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB2021-YX-056-01