Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 10:52 AM
Study NCT ID:
NCT04928534
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2021-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of Blood Biomarkers for TES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070627', 'term': 'Chronic Traumatic Encephalopathy'}, {'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020208', 'term': 'Brain Injury, Chronic'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-10', 'size': 205148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-18T20:50', 'hasProtocol': True}, {'date': '2021-06-10', 'size': 4832925, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-18T20:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood level of novel protein biomarkers for CTE/TES', 'timeFrame': 'Baseline', 'description': 'Novel protein biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using ELISA assay.'}, {'measure': 'Blood level of novel RNA biomarkers for CTE/TES', 'timeFrame': 'Baseline', 'description': 'Novel RNA biomarkers for CTE/TES will be screened out by transcriptomics + proteomics high-throughput detection and multi-omics bioinformatics analysis. Their levels will be further verified using RT-PCR.'}], 'secondaryOutcomes': [{'measure': 'Blood level of classical biomarkers for CTE/TES', 'timeFrame': 'Baseline', 'description': 'Blood S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181 level detected by ELISA assay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Traumatic Encephalopathy', 'Traumatic Encephalopathy, Chronic', 'Traumatic; Encephalopathy, Postcontusional']}, 'descriptionModule': {'briefSummary': 'In this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential CTE/TES biomarkers (RNA and protein) in blood and its exosomes. Thereafter, these biomarkers will be combined with the reported TBI biomarkers to create a novel set of CTE/TES molecular diagnostic signatures. The findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Athletes with rmTBI history. The subjects are active or retired athletes who have engaged in weightlifting, wrestling, judo, boxing or taekwondo. All of them have a clear history of rmTBI.\n* Patients with rmTBI history. The subjects have a history of multiple (≥2 times) exposure to brain trauma, and medical records in Tianjin Medical Insurance designated hospitals.\n* Healthy volunteers, without rmTBI history.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Athletes and patients with traumatic brain injury\n\n * Age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative.\n * Have a clear history of repetitive mild TBI, concussion or subconcussion.\n * The most recent head injury occurred 3 months ago.\n2. Healthy Volunteers\n\n * Age ≥ 18 and ≤ 80 years old with independent behavior ability.\n * No history of repetitive mild TBI, concussion or subconcussion.\n * Fully understands the nature of the study, and voluntarily participates and signs the informed consent.\n\nExclusion Criteria:\n\n1. Athletes and patients with traumatic brain injury\n\n * Pregnant or lactating women.\n * History of other neurological diseases.\n * History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.\n * Have participated in clinical trials in the past four weeks.\n * The investigator believes that not appropriate for inclusion.\n2. Healthy Volunteers\n\n * Pregnant or lactating women.\n * History of TBI or other neurological diseases.\n * History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.\n * Have participated in clinical trials in the past four weeks.\n * The investigator believe that not appropriate for inclusion.'}, 'identificationModule': {'nctId': 'NCT04928534', 'briefTitle': 'Cohort Study of Blood Biomarkers for TES', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University'}, 'officialTitle': 'Observational Cohort Study of Blood Transcriptomics and Proteomics Information as Biomarkers of Traumatic Encephalopathy Syndrome', 'orgStudyIdInfo': {'id': 'IRB2021-YX-056-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Athletes with rmTBI history', 'description': '50 active or retired athletes from the Weightlifting, Wrestling, Judo, Boxing and Taekwondo Sports Management Center of Tianjin Sports Bureau', 'interventionNames': ['Diagnostic Test: Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination']}, {'label': 'Patients with rmTBI history', 'description': '50 patients with multiple (≥2 times) exposure to brain trauma attending Tianjin Medical Insurance designated hospitals such as Tianjin Medical University General Hospital', 'interventionNames': ['Diagnostic Test: Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination']}, {'label': 'Healthy volunteer', 'description': '20 healthy volunteers', 'interventionNames': ['Diagnostic Test: Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination']}], 'interventions': [{'name': 'Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181.\n2. Cognitive function tests, including RPQ, MMSE and MoCA.\n3. Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination', 'armGroupLabels': ['Athletes with rmTBI history', 'Healthy volunteer', 'Patients with rmTBI history']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Ping Lei, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xintong Ge', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}