Stroke, IschemicNCT03291392
CUHK Stroke Biobank
An observational study of Stroke, Ischemic and Genetic Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Genetic Disease, Atherosclerosis, Cerebral
- What is being tested?
- Gene expression or biomarkers exploration
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2015to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Chinese ONLY 2. Patients with intracranial stenosis or extracranial stenosis equal to or >70% 3. Stroke patients and their family members 4. Normal subject without any intracranial stenosis/ extracranial stenosis
Who may be able to join
- Adult equal or more 18 years of age and Chinese ONLY.
- Stroke patients, their family members, and/or the normal subjects without intracranial stenosis or extracranial stenosis, are eligible to join the study.
- Subject is willing to have blood taken, cerebral spinal fluid and/or body tissue drawn for storage in the research bank.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Thomas Wai Hong LEUNG, FRCP, 852-35053593, drtleung@cuhk.edu.hk
Anki MIU, MSc, 852-28902002, ankimiu@cuhk.edu.hk
About this study
The purpose of the study are:
- To make quality, characterized samples and related data available for future studies, including Genome Wide Association Studies (GWAS), genomics, and biomarker research;
- 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;
- 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.
Read the 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.
- Conditions
- Stroke, Ischemic, Genetic Disease, Atherosclerosis, Cerebral
- Being tested
- Gene expression or biomarkers exploration
- Keywords
- Genetics, Stroke, Biobank, Atherosclerosis
- Medical subject headings
- Ischemic Stroke, Genetic Diseases, Inborn, Intracranial Arteriosclerosis, Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene expression or biomarkers explorationGenetic
| Study group | Role | What they receive |
|---|---|---|
| Atherosclerosis | 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 Receives: Genetic: Gene expression or biomarkers exploration | |
| Family members | 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 Receives: Genetic: Gene expression or biomarkers exploration | |
| Normal subjects | 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 Receives: Genetic: Gene expression or biomarkers exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke-related genetics
- 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.
- Replication of novel genetic markers of stroke will be performed using a combination of genotyping, multiplex genotyping, customized-content genotyping arrays and sequencing.
Measured: Dec, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start15 Jun 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Wai Hong Thomas, Chinese University of Hong Kong
- Investigators
- Thomas Wai Hong LEUNG, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291392
- Sponsor's protocol ID
- crec no. 2014.582
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2017
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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. In 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CUHK Stroke Biobank
- ClinicalTrials.gov ID
- NCT03291392
- Acronym / sponsor ID
- crec no. 2014.582
- Conditions
- Stroke, Ischemic, Genetic Disease, Atherosclerosis, Cerebral
- Keywords
- Genetics, Stroke, Biobank, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study are:
- To make quality, characterized samples and related data available for future studies, including Genome Wide Association Studies (GWAS), genomics, and biomarker research;
- 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;
- 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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atherosclerosis | – | Genetic: Gene expression or biomarkers explorationPatient 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 | – | Genetic: Gene expression or biomarkers explorationThe 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 | – | Genetic: Gene expression or biomarkers explorationNormal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Chinese ONLY 2. Patients with intracranial stenosis or extracranial stenosis equal to or >70% 3. Stroke patients and their family members 4. Normal subject without any intracranial stenosis/ extracranial stenosis
Key inclusion criteria (3 listed)
- Adult equal or more 18 years of age and Chinese ONLY.
- Stroke patients, their family members, and/or the normal subjects without intracranial stenosis or extracranial stenosis, are eligible to join the study.
- Subject is willing to have blood taken, cerebral spinal fluid and/or body tissue drawn for storage in the research bank.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene expression or biomarkers exploration | Genetic | Atherosclerosis, Family members, Normal subjects |
Primary outcome
Ischemic stroke-related genetics
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided. 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. In 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Wai Hong LEUNG, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Genetic Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Wai Hong LEUNG, FRCP (852-35053593, drtleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic stroke-related genetics (time frame: Dec, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.