Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-03-06 @ 2:55 PM
Study NCT ID:
NCT03291392
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2017-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CUHK Stroke Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015870', 'term': 'Gene Expression'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '30ml of EDTA blood, buccal swab or saliva, body tissue, or cerebrospinal fluid to be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic stroke-related genetics', 'timeFrame': 'Dec, 2025', 'description': '1. Discovery of novel genetic predictor of stroke and its complications will be done by identifying cases and controls for different stroke subtype and complications within the recruited samples, and using whole-genome genotyping arrays, or by sequencing approaches.\n2. Replication of novel genetic markers of stroke will be performed using a combination of genotyping, multiplex genotyping, customized-content genotyping arrays and sequencing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetics', 'Stroke', 'Biobank', 'Atherosclerosis'], 'conditions': ['Stroke, Ischemic', 'Genetic Disease', 'Atherosclerosis, Cerebral']}, 'descriptionModule': {'briefSummary': 'The purpose of the study are:\n\n1. To make quality, characterized samples and related data available for future studies, including Genome Wide Association Studies (GWAS), genomics, and biomarker research;\n2. To use these samples and related medical information to answer research questions aimed at understanding the genetics and underlying biology of acquired disease and injury to the brain, heart and blood vessels with the express purpose of advancing the search for effective modalities for prevention, treatment, and recovery;\n3. To develop additional operational infrastructure to support this project across the Prince of Wales Hospital and divisions, including (1) tracking of patient consent, (2) management of collection and sample processing processes, (3) sample inventory and QC/QA processes, and (4) release of materials to investigators for further research.', 'detailedDescription': "TYPES OF TISSUES TO BE BANKED\n\nBlood:\n\nBlood will be collected from the out-patient clinic, prospectively at the time of a clinically planned procedure or prospectively during a procedure performed solely for research. After informed consent is obtained, the patient/ subject will be asked to donate a one-time blood sample of up to 30ml. A portion of each blood sample will be used to generate a DNA sample, and the remainder will be used to separate out plasma, peripheral blood cells, and/or serum for future research studies, including but not limited to metabolomics, proteomics, biomarker measurements, and bioenergetic assays.\n\nCerebrospinal Fluid:\n\nCerebrospinal fluid 5-10ml may be collected prospectively from lumbar puncture or the subset of patients who have an external ventricular drain (EVD) placed as part of their clinical care. The standard clinical protocol for EVD includes the drainage of CSF externally into a collection bag. Once the volume of CSF drainage is recorded, the CSF is typically discarded. The collection of CSF will be coordinated with the subject's primary treatment team. At this time, CSF banking will not occur in subjects who do not have CSF collection planned as part of their clinical care.\n\nBody Tissue:\n\nThe body tissue will be collected from the patients who undergo the carotid stent which is their routine medical treatment. Around 5mg tissue will be taken from the filter wire during the stenting operation and then stabilized by RNAlater reagent immediately. The tissue will be kept in -80oC freezer for future process.\n\nBuccal swab or saliva:\n\nBuccal swab or saliva (\\~5-10ml) may be collected from the patients, their family members and/or normal subjects for DNA and RNA extraction if necessary. It would be collected by the trained doctor, medical staffs or research assistant. The collected samples will be kept in -80oC freezer for future use, for example, extraction of DNA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Chinese ONLY\n2. Patients with intracranial stenosis or extracranial stenosis equal to or \\>70%\n3. Stroke patients and their family members\n4. Normal subject without any intracranial stenosis/ extracranial stenosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult equal or more 18 years of age and Chinese ONLY.\n2. Stroke patients, their family members, and/or the normal subjects without intracranial stenosis or extracranial stenosis, are eligible to join the study.\n3. Subject is willing to have blood taken, cerebral spinal fluid and/or body tissue drawn for storage in the research bank.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03291392', 'briefTitle': 'CUHK Stroke Biobank', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'CUHK Stroke Biobank', 'orgStudyIdInfo': {'id': 'crec no. 2014.582'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atherosclerosis', 'description': 'Patient with intracranial stenosis or extracranial stenosis equal to or more than 70% would be invited to join the study for blood taking.\n\nBiobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases', 'interventionNames': ['Genetic: Gene expression or biomarkers exploration']}, {'label': 'Family members', 'description': 'The stroke patient who had family history of stroke, their parents and siblings would also be invited to join the study for blood taking or buccal swab/ saliva collection.\n\nBiobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases', 'interventionNames': ['Genetic: Gene expression or biomarkers exploration']}, {'label': 'Normal subjects', 'description': 'Normal subjects without ischemic stroke or intracranial/extracranial stenosis would be invited to join the study for blood taking.\n\nBiobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases', 'interventionNames': ['Genetic: Gene expression or biomarkers exploration']}], 'interventions': [{'name': 'Gene expression or biomarkers exploration', 'type': 'GENETIC', 'armGroupLabels': ['Atherosclerosis', 'Family members', 'Normal subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Thomas Wai Hong LEUNG, FRCP', 'role': 'CONTACT', 'email': 'drtleung@cuhk.edu.hk', 'phone': '852-35053593'}, {'name': 'Anki MIU, MSc', 'role': 'CONTACT', 'email': 'ankimiu@cuhk.edu.hk', 'phone': '852-28902002'}], 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Thomas Wai Hong LEUNG, FRCP', 'role': 'CONTACT', 'email': 'drtleung@cuhk.edu.hk', 'phone': '852-35053593'}], 'overallOfficials': [{'name': 'Thomas Wai Hong LEUNG, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Tissues and data from the repository will only be shared with other academic, non-profit institutions. No collaboration with for-profit companies is anticipated. All investigators seeking to gain access to the repository must first demonstrate that their research interests are relevant to the central theme of the repository. Investigators must also complete all required IRB documentation before samples and information will be released.\n\nIn the event that a commercial, for-profit, collaboration is sought, a bona fide intellectual collaboration between the PI and an individual or group at the for-profit site and a Materials Transfer Agreement will be required. For all researchers requesting samples, the IRB recommended Letter of Agreement must be signed prior to our releasing tissues and information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Leung Wai Hong Thomas', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}