CUHK Stroke Biobank

Recruiting

• Conditions: Atherosclerosis, Cerebral; Stroke, Ischemic; Genetic Disease
• Interventions: Genetic: Gene expression or biomarkers exploration

• Registration Number: NCT03291392
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The purpose of the study are:

1. To make quality, characterized samples and related data available for future studies, including Genome Wide Association Studies (GWAS), genomics, and biomarker research;

2. 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;

3. 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.

Detailed Description

TYPES OF TISSUES TO BE BANKED

Blood:

Blood 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.

Cerebrospinal Fluid:

Cerebrospinal 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.

Body Tissue:

The 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.

Buccal swab or saliva:

Buccal 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.

Study Timeline

• Study Start: 2015-06-15
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Adult equal or more 18 years of age and Chinese ONLY.
2. Stroke patients, their family members, and/or the normal subjects without intracranial stenosis or extracranial stenosis, are eligible to join the study.
3. Subject is willing to have blood taken, cerebral spinal fluid and/or body tissue drawn for storage in the research bank.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atherosclerosis	Gene expression or biomarkers exploration	Patient with intracranial stenosis or extracranial stenosis equal to or more than 70% would be invited to join the study for blood taking. Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases
Family members	Gene expression or biomarkers exploration	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. Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases
Normal subjects	Gene expression or biomarkers exploration	Normal subjects without ischemic stroke or intracranial/extracranial stenosis would be invited to join the study for blood taking. Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases

Primary Outcome Measures

Name	Time	Method
Ischemic stroke-related genetics	Dec, 2025	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.; 2. Replication of novel genetic markers of stroke will be performed using a combination of genotyping, multiplex genotyping, customized-content genotyping arrays and sequencing.

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong