Clinical trial NCT03291392: CUHK Stroke Biobank
Official title: CUHK Stroke Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Ischemic
Genetic Disease
Atherosclerosis, Cerebral
Keywords: Genetics
Stroke
Biobank
Atherosclerosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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

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.

Eligibility 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:

* None

Primary outcomes:
measure: Ischemic stroke-related genetics
timeFrame: Dec, 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Thomas Wai Hong LEUNG, FRCP
role: PRINCIPAL_INVESTIGATOR
References: