Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 2:26 PM
Study NCT ID:
NCT05533060
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2022-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '1. Brain tissues removed by decompression in patients with traumatic brain injury (TBI)\n2. Cerebrospinal fluid (CSF)\n3. Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Accurate assessment of patients' neurological condition", 'timeFrame': '2022.09-2023.12', 'description': "Using a regression model to explore the relationship between a patient's neurological condition and clinical and molecular biological data"}], 'secondaryOutcomes': [{'measure': "Predicting patients' outcome accurately", 'timeFrame': '2022.09-2023.12', 'description': "Using a regression model to explore the relationship between a patient's prognosis and clinical and molecular biological data"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic brain injury', 'Molecular biomarkers', 'Single-cell sequencing', 'High-throughput sequencing'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with traumatic brain injury (TBI) or other brain diseases (gliomas, meningiomas, schwannoma) who are treated surgically', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CT/MRI confirmed TBI;\n* The time from onset to the emergency room (ER ) within 12h;\n* The systolic pressure (SBP) ≥ 90 mmHg;\n* Patients willing to participate in this study with signed informed consent.\n\nExclusion Criteria:\n\n* Patients who are not suitable for surgery (GCS score 3 points, dilated and fixed bilateral pupils, pregnant women, etc.);\n* Pre-injury life expectancy ≤ 1 year (malignant tumor);\n* Previous history of acute myocardial infarction, abnormal immune function, and blood-related diseases;\n* without informed consent.'}, 'identificationModule': {'nctId': 'NCT05533060', 'briefTitle': 'Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Clinical and Molecular Biological Data Collection and Analysis in Patients With Traumatic Brain Injury (TBI)', 'orgStudyIdInfo': {'id': '2022-KY-13(K)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TBI group', 'description': 'patients with traumatic brain injury (TBI) treated surgically', 'interventionNames': ['Other: No intervention']}, {'label': 'RN group', 'description': 'relatively normal (RN) participants including patients with other brain diseases, for example, gliomas, meningiomas, and schwannomas, treated surgically', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'patients in the groups are treated surgically and brain tissue, CSF, and blood samples, as well as clinical data, neuroimaging data are collected', 'armGroupLabels': ['RN group', 'TBI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Chen, M.D., Ph.D.', 'role': 'CONTACT'}], 'facility': "Shanghai 6th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yang Yang, MD, PhD', 'role': 'CONTACT', 'email': 'yang.cne.yang@gmail.com', 'phone': '18210391762'}], 'overallOfficials': [{'name': 'Hengli Tian, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanghai 6th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD could be available on from the central contact person with a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor, Supervisor', 'investigatorFullName': 'Hao Chen, MD, PhD', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}