Cohort Study of Blood Biomarkers for TES

Chronic Traumatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928534
• Other study ID #: IRB2021-YX-056-01
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2023
• Source: Tianjin Medical University
• Contact: Xintong Ge, Doctor
• Phone: 86-022-60364359
• Email: xge[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Damage, Chronic
• Brain Diseases
• Brain Injuries, Traumatic
• Chronic Traumatic Encephalopathy

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University	Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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