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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533060
• Other study ID #: 2022-KY-13(K)
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 30, 2027

Study information

• Verified date: January 2024
• Source: Shanghai 6th People's Hospital
• Contact: Yang Yang, MD, PhD
• Phone: 18210391762
• Email: yang.cne.yang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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