Clinical trial NCT04928534: Cohort Study of Blood Biomarkers for TES
Official title: Observational Cohort Study of Blood Transcriptomics and Proteomics Information as Biomarkers of Traumatic Encephalopathy Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Traumatic Encephalopathy
Traumatic Encephalopathy, Chronic
Traumatic; Encephalopathy, Postcontusional
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2021-06-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Athletes with rmTBI history. The subjects are active or retired athletes who have engaged in weightlifting, wrestling, judo, boxing or taekwondo. All of them have a clear history of rmTBI.
* Patients with rmTBI history. The subjects have a history of multiple (≥2 times) exposure to brain trauma, and medical records in Tianjin Medical Insurance designated hospitals.
* Healthy volunteers, without rmTBI history.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood level of novel protein biomarkers for CTE/TES
timeFrame: Baseline
measure: Blood level of novel RNA biomarkers for CTE/TES
timeFrame: Baseline
Secondary outcomes:
measure: Blood level of classical biomarkers for CTE/TES
timeFrame: Baseline
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University
name: Ping Lei, Doctor
role: PRINCIPAL_INVESTIGATOR
References: