Cohort Study of Blood Biomarkers for TES

Tianjin Medical University

Status: Completed

Conditions: Traumatic; Encephalopathy, Postcontusional; Chronic Traumatic Encephalopathy; Traumatic Encephalopathy, Chronic

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT04928534

IRB2021-YX-056-01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 3 patient groups

Athletes with rmTBI history

Description:

50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau

Treatment:

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

Description:

50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital

Treatment:

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

Description:

20 healthy volunteers

Treatment:

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