We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CUHK Stroke Biobank

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03291392
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Leung Wai Hong Thomas, 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.

Condition or disease Intervention/treatment
Stroke, Ischemic Genetic Disease Atherosclerosis, Cerebral Genetic: Gene expression or biomarkers exploration

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 : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Official Title: CUHK Stroke Biobank
Actual Study Start Date : June 15, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
30ml of EDTA blood, buccal swab or saliva, body tissue, or cerebrospinal fluid to be collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291392


Contacts
Contact: Thomas Wai Hong LEUNG, FRCP 852-35053846 drtleung@cuhk.edu.hk

Locations
Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Thomas Wai Hong LEUNG, FRCP    852-35053846    drtleung@cuhk.edu.hk   
Contact: Tiffany Chung, M.Phil    852-35053856    tchung@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Thomas Wai Hong LEUNG, FRCP Chinese University of Hong Kong

Responsible Party: Leung Wai Hong Thomas, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03291392     History of Changes
Other Study ID Numbers: crec no. 2014.582
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leung Wai Hong Thomas, Chinese University of Hong Kong:
Genetics
Stroke
Biobank
Atherosclerosis

Additional relevant MeSH terms:
Stroke
Atherosclerosis
Genetic Diseases, Inborn
Intracranial Arteriosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Intracranial Arterial Diseases