<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03291392</url>
  </required_header>
  <id_info>
    <org_study_id>crec no. 2014.582</org_study_id>
    <nct_id>NCT03291392</nct_id>
  </id_info>
  <brief_title>CUHK Stroke Biobank</brief_title>
  <official_title>CUHK Stroke Biobank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study are:&#xD;
&#xD;
        1. To make quality, characterized samples and related data available for future studies,&#xD;
           including Genome Wide Association Studies (GWAS), genomics, and biomarker research;&#xD;
&#xD;
        2. To use these samples and related medical information to answer research questions aimed&#xD;
           at understanding the genetics and underlying biology of acquired disease and injury to&#xD;
           the brain, heart and blood vessels with the express purpose of advancing the search for&#xD;
           effective modalities for prevention, treatment, and recovery;&#xD;
&#xD;
        3. To develop additional operational infrastructure to support this project across the&#xD;
           Prince of Wales Hospital and divisions, including (1) tracking of patient consent, (2)&#xD;
           management of collection and sample processing processes, (3) sample inventory and QC/QA&#xD;
           processes, and (4) release of materials to investigators for further research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TYPES OF TISSUES TO BE BANKED&#xD;
&#xD;
      Blood:&#xD;
&#xD;
      Blood will be collected from the out-patient clinic, prospectively at the time of a&#xD;
      clinically planned procedure or prospectively during a procedure performed solely for&#xD;
      research. After informed consent is obtained, the patient/ subject will be asked to donate a&#xD;
      one-time blood sample of up to 30ml. A portion of each blood sample will be used to generate&#xD;
      a DNA sample, and the remainder will be used to separate out plasma, peripheral blood cells,&#xD;
      and/or serum for future research studies, including but not limited to metabolomics,&#xD;
      proteomics, biomarker measurements, and bioenergetic assays.&#xD;
&#xD;
      Cerebrospinal Fluid:&#xD;
&#xD;
      Cerebrospinal fluid 5-10ml may be collected prospectively from lumbar puncture or the subset&#xD;
      of patients who have an external ventricular drain (EVD) placed as part of their clinical&#xD;
      care. The standard clinical protocol for EVD includes the drainage of CSF externally into a&#xD;
      collection bag. Once the volume of CSF drainage is recorded, the CSF is typically discarded.&#xD;
      The collection of CSF will be coordinated with the subject's primary treatment team. At this&#xD;
      time, CSF banking will not occur in subjects who do not have CSF collection planned as part&#xD;
      of their clinical care.&#xD;
&#xD;
      Body Tissue:&#xD;
&#xD;
      The body tissue will be collected from the patients who undergo the carotid stent which is&#xD;
      their routine medical treatment. Around 5mg tissue will be taken from the filter wire during&#xD;
      the stenting operation and then stabilized by RNAlater reagent immediately. The tissue will&#xD;
      be kept in -80oC freezer for future process.&#xD;
&#xD;
      Buccal swab or saliva:&#xD;
&#xD;
      Buccal swab or saliva (~5-10ml) may be collected from the patients, their family members&#xD;
      and/or normal subjects for DNA and RNA extraction if necessary. It would be collected by the&#xD;
      trained doctor, medical staffs or research assistant. The collected samples will be kept in&#xD;
      -80oC freezer for future use, for example, extraction of DNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ischemic stroke-related genetics</measure>
    <time_frame>Dec, 2025</time_frame>
    <description>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.&#xD;
Replication of novel genetic markers of stroke will be performed using a combination of genotyping, multiplex genotyping, customized-content genotyping arrays and sequencing.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Stroke, Ischemic</condition>
  <condition>Genetic Disease</condition>
  <condition>Atherosclerosis, Cerebral</condition>
  <arm_group>
    <arm_group_label>Atherosclerosis</arm_group_label>
    <description>Patient with intracranial stenosis or extracranial stenosis equal to or more than 70% would be invited to join the study for blood taking.&#xD;
Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family members</arm_group_label>
    <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.&#xD;
Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal subjects</arm_group_label>
    <description>Normal subjects without ischemic stroke or intracranial/extracranial stenosis would be invited to join the study for blood taking.&#xD;
Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Gene expression or biomarkers exploration</intervention_name>
    <arm_group_label>Atherosclerosis</arm_group_label>
    <arm_group_label>Family members</arm_group_label>
    <arm_group_label>Normal subjects</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      30ml of EDTA blood, buccal swab or saliva, body tissue, or cerebrospinal fluid to be&#xD;
      collected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Chinese ONLY&#xD;
&#xD;
          2. Patients with intracranial stenosis or extracranial stenosis equal to or &gt;70%&#xD;
&#xD;
          3. Stroke patients and their family members&#xD;
&#xD;
          4. Normal subject without any intracranial stenosis/ extracranial stenosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult equal or more 18 years of age and Chinese ONLY.&#xD;
&#xD;
          2. Stroke patients, their family members, and/or the normal subjects without intracranial&#xD;
             stenosis or extracranial stenosis, are eligible to join the study.&#xD;
&#xD;
          3. Subject is willing to have blood taken, cerebral spinal fluid and/or body tissue drawn&#xD;
             for storage in the research bank.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Wai Hong LEUNG, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Wai Hong LEUNG, FRCP</last_name>
    <phone>852-35053593</phone>
    <email>drtleung@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Wai Hong LEUNG, FRCP</last_name>
      <phone>852-35053593</phone>
      <email>drtleung@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Anki MIU, MSc</last_name>
      <phone>852-28902002</phone>
      <email>ankimiu@cuhk.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Leung Wai Hong Thomas</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Genetics</keyword>
  <keyword>Stroke</keyword>
  <keyword>Biobank</keyword>
  <keyword>Atherosclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Intracranial Arteriosclerosis</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Genetic Diseases, Inborn</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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.&#xD;
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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03291392
org study id: crec no. 2014.582
nct id: NCT03291392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Other
measure: Ischemic stroke-related genetics
time frame: Dec, 2025
description: 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.
arm group 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.
Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases
arm group 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.
Biobank: Gene expression or biomarkers exploration for atherosclerotic-related genetic diseases
arm group label: Normal subjects
description: 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
intervention type: Genetic
intervention name: Gene expression or biomarkers exploration
arm group label: Atherosclerosis
arm group label: Family members
arm group label: Normal subjects
30ml of EDTA blood, buccal swab or saliva, body tissue, or cerebrospinal fluid to be
      collected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Wai Hong LEUNG, FRCP
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Thomas Wai Hong LEUNG, FRCP
phone: 852-35053593
email: drtleung@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Leung Wai Hong Thomas
investigator title: Professor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Intracranial Arteriosclerosis
mesh term: Atherosclerosis
mesh term: Genetic Diseases, Inborn
sharing ipd: Undecided
ipd 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.