Observational Cohort Study of Blood Transcriptomics and Proteomics Information as Biomarkers of Traumatic Encephalopathy Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Blood level of novel protein biomarkers for CTE/TES
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Athletes with rmTBI history
50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau
干预措施: 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)
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
干预措施: 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)
Healthy volunteer
20 healthy volunteers
干预措施: 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)
结局指标
主要结局
Blood level of novel protein biomarkers for CTE/TES
时间窗: 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
时间窗: 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.
次要结局
- Blood level of classical biomarkers for CTE/TES(Baseline)
- Ultrasound examination of the carotid arteries and lower limb arteries(5 years post-enrollment)
- Serum Treg cell count and degree of senescence(5 years post-enrollment)
- Cognitive function tests - RPQ-3(5 years post-enrollment)
- Cognitive function tests - RPQ-16(5 years post-enrollment)
- Cognitive function tests - MoCA(5 years post-enrollment)
- Cognitive function tests - MMSE(5 years post-enrollment)
研究者
Xintong Ge
Principal Investigator
Tianjin Medical University General Hospital