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Cohort Study of Blood Biomarkers for TES

T

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

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Xintong Ge, Doctor

Data sourced from clinicaltrials.gov

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