CUHK Stroke Biobank

February 21, 2026 updated by: Leung Wai Hong Thomas, Chinese University of Hong Kong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
Genetic: Gene expression or biomarkers exploration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Dec, 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Wai Hong LEUNG, FRCP, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • crec no. 2014.582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan 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.

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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