Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI

Clinical and Molecular Biological Data Collection and Analysis in Patients With Traumatic Brain Injury (TBI)

Clinical evaluation is crucial in the clinical diagnosis, treatment, and prognosis prediction in patients with traumatic brain injury (TBI). However, the existing evaluation systems are not perfect, because many factors are not taken into account, for example, there is a lack of molecular diagnostic criteria for evaluating patients with TBI. We attempt to collect the patient's clinical data and combine it with neuroimaging, as well as molecular biomarkers generated by single-cell sequencing to assess their neurological status and outcome. The clinical and molecular data collection and analysis will be helpful to evaluate the patient's neurological condition and predict the patient's outcome more accurately.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: No intervention

Detailed Description

Specifically, eligible patients will be treated surgically. In one group, injured brain tissue removed during decompression and resection will be preserved in a tissue preservation solution. In another group, brain tissue in the surgical trajectory during surgical resection of the brain lesion (for example, gliomas, meningiomas, schwannomas) will be also preserved in the solution. Then these tissues will be analyzed through high-throughput single-cell sequencing and bioinformatics analysis. In order to obtain the most changed biomarkers, we will pick up the top 10 cell subgroups with 10 expression biomarkers in each subgroup to compare them with the results analyzed in the mice brain tissue. The target biomarkers will be validated in the cerebrospinal fluid (CSF) and blood in patients with TBI for the patient's neurological status evaluation and outcome prediction. At the same time, the patient's pre- and postoperative clinical data (including, gender, age, GCS score, pupil light reflection, CT results, etc) will also be collected. A regression model will be generated to estimate the relationship between the patient's neurological status and these independent variables. In addition, the association between a patient's prognosis and these factors will also be analyzed. ROC curve will be used to compare our regression model to the established GCS score scale and Marshall CT grading.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yang Yang, MD, PhD; Phone Number: 18210391762; Email: yang.cne.yang@gmail.com

Study Locations

• China
  • Shanghai, China, 200233
    • Recruiting
    • Shanghai 6th People's Hospital
    • Contact: Hao Chen, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with traumatic brain injury (TBI) or other brain diseases (gliomas, meningiomas, schwannoma) who are treated surgically

Description

Inclusion Criteria:

• CT/MRI confirmed TBI;
• The time from onset to the emergency room (ER ) within 12h;
• The systolic pressure (SBP) ≥ 90 mmHg;
• Patients willing to participate in this study with signed informed consent.

Exclusion Criteria:

• Patients who are not suitable for surgery (GCS score 3 points, dilated and fixed bilateral pupils, pregnant women, etc.);
• Pre-injury life expectancy ≤ 1 year (malignant tumor);
• Previous history of acute myocardial infarction, abnormal immune function, and blood-related diseases;
• without informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TBI group; patients with traumatic brain injury (TBI) treated surgically	Other: No intervention; patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected
RN group; relatively normal (RN) participants including patients with other brain diseases, for example, gliomas, meningiomas, and schwannomas, treated surgically	Other: No intervention; patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurate assessment of patients' neurological condition	Using a regression model to explore the relationship between a patient's neurological condition and clinical and molecular biological data	2022.09-2023.12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicting patients' outcome accurately	Using a regression model to explore the relationship between a patient's prognosis and clinical and molecular biological data	2022.09-2023.12

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Study Director: Hengli Tian, MD, PhD, Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Molecular biomarkers; Single-cell sequencing; High-throughput sequencing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2022-KY-13(K)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD could be available on from the central contact person with a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No