Clinical trial NCT05533060: Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI
Official title: Clinical and Molecular Biological Data Collection and Analysis in Patients With Traumatic Brain Injury (TBI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Molecular biomarkers
Single-cell sequencing
High-throughput sequencing
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with traumatic brain injury (TBI) or other brain diseases (gliomas, meningiomas, schwannoma) who are treated surgically

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accurate assessment of patients' neurological condition
timeFrame: 2022.09-2023.12
Secondary outcomes:
measure: Predicting patients' outcome accurately
timeFrame: 2022.09-2023.12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Hengli Tian, MD, PhD
role: STUDY_DIRECTOR
References: