Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT03611166
Status:
UNKNOWN
Last Update Posted:
2018-08-02
First Post:
2018-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteomics for Chronic Disorder of Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood (5 mL) was collected in a Vacutainer® tube, containing anticoagulant, using standardized phlebotomy procedures. Plasma was prepared by centrifugation (2,000 g, 5 min, 4°C) and stored at -80°C until further analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2018-03-18', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein profiling', 'timeFrame': 'Three months', 'description': 'A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls.'}], 'secondaryOutcomes': [{'measure': 'Glasgow Outcome Scale (GOS)', 'timeFrame': 'In one year', 'description': 'A GOS value of \\<3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery.'}, {'measure': 'Coma Recovery Scale-Revised(CRS-R)', 'timeFrame': '30 minutes before blood collection', 'description': 'Coma Recovery Scale-Revised (CRS-R) score was used to quantify the severity, which consists of 23 hierarchically arranged items that comprise six subscales addressing auditory, visual, motor, oromotor/verbal, communication, and arousal processes. The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proteomics', 'plasma', 'chronic disorder of consciousness'], 'conditions': ['Disorder of Consciousness']}, 'descriptionModule': {'briefSummary': 'Following severe traumatic brain injury, patients may remain unconscious for many years. It is the first proteomic analysis comparing differentially expressed proteins between patients with chronic disorder of consciousness and controls so far. The investigators generated accurate lists of proteomes and identified differences at different disease time courses. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness.', 'detailedDescription': 'Background: Patients who awake from severely traumatic brain injury (sTBI) may remain unconscious for many years. Although behavioral assessment and functional imaging are currently used as diagnostic tools, the molecular basis underlying chronic condition has yet to be explored.\n\nObjective:To explore the molecular basis and identify novel biomarkers for the diagnosis and prognosis of patients with chronic disorder of consciousness.\n\nMethod: Plasma samples were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls. Potential molecular mechanisms were further discussed through bioinformatics analyses. Candidate proteins were validated by enzyme-linked immunosorbent assay (ELISA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic disorder of consciousness were recruited at the rehabilitation units of Hangzhou Wujing Hospital (Hangzhou, Zhejiang, China).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ages 14 to 65 years old;\n2. Patients had a history of sTBI;\n3. Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;\n4. Patients stay unconscious for more than 1 month.\n\nExclusion Criteria:\n\n1. Patients with acute infectious diseases or liver dysfunction;\n2. Patients with serious diseases such as cardiac or pulmonary problems.'}, 'identificationModule': {'nctId': 'NCT03611166', 'briefTitle': 'Proteomics for Chronic Disorder of Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'iTRAQ-Based Proteomics Reveals Potential Biomarkers for Chronic Disorder of Consciousness', 'orgStudyIdInfo': {'id': 'proteomics'}}, 'contactsLocationsModule': {'locations': [{'zip': '310001', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wangxiao Bao, PHD', 'role': 'CONTACT', 'email': 'baowangxiao@zju.edu.cn', 'phone': '(86)15057137653'}], 'facility': 'Hangzhou Hospital of Zhejiang CAPR', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wangxiao Bao, PHD', 'role': 'CONTACT', 'email': 'baowangxiao@zju.edu.cn', 'phone': '(86)15057137653'}, {'name': 'Fangping He, PHD', 'role': 'CONTACT', 'email': 'hefangping@126.com', 'phone': '(86)13819114225'}], 'overallOfficials': [{'name': 'Benyan Luo, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou'}, {'name': 'Jian Gao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hangzhou Hospital of Zhejiang CAPR,Hangzhou, Zhejiang, China'}, {'name': 'Hai Zou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou, PR China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}