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

NCT ID: NCT05533060

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2027-12-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

TBI group

patients with traumatic brain injury (TBI) treated surgically

No intervention

Intervention Type: OTHER

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

No intervention

Intervention Type: OTHER

patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected

Interventions

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

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Chen, MD, PhD

Associate Clinical Professor, Supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hengli Tian, MD, PhD

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Locations

Shanghai 6th People's Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Yang, MD, PhD

Role: CONTACT

yang.cne.yang@gmail.com

18210391762

Facility Contacts

Hao Chen, M.D., Ph.D.

Role: primary

Other Identifiers

2022-KY-13(K)

Identifier Type: -

Identifier Source: org_study_id