Fabry DiseaseNCT03596398
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients
An observational study of Fabry Disease, run by Chiayi Christian Hospital.
Trial summary
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Fabry Disease
- What is being tested?
- GLA gene
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young stroke
Who may be able to join
- Patients aged 20 or over
- Patients aged under 56 years old, not included 56
- Patients with acute stroke
- Patients and/or their legal representatives are willing to provide written informed consent
Who cannot join
- Patients with a confirmed diagnosis of Fabry disease
About this study
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients
Read the detailed description
This is a cross-sectional, population-based study. No randomization procedure will be executed in this study. Approximately 1000 subjects over a 36-month period. The aim of this screening study is to identify the Fabry disease as the cause in patients with young stroke.
To measure the level of α-Gal A activity, male subjects will initially provide a DBS sample and female subjects will start with a test by whole blood sample.
The prevalence of Fabry disease among patients with young stroke will be estimated by a confirmative diagnosis in gene testing.
- Conditions
- Fabry Disease
- Being tested
- GLA gene
- Keywords
- Fabry disease, Young stroke
- Medical subject headings
- Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA geneGenetic
Genetic test will be performed when enzyme activity is found abnormal in the whole blood test or confirmation is required. 5 ml of blood sample will be obtained and polymerase chain reaction (PCR) sequencing will be executed to determine mutations in the GLA gene.
| Study group | Role | What they receive |
|---|---|---|
| Young stroke | Patients with acute stroke aged 20 or over, and under 56 years old (Not included 56) . Receives: Genetic: GLA gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fabry disease
The prevalence of Fabry disease in patients with young stroke
Measured: 3 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Jan 2016
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596398
- Sponsor's protocol ID
- 105028
- Status last verified
- Jul 2018
- First submitted
- 15 Jun 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients
- ClinicalTrials.gov ID
- NCT03596398
- Acronym / sponsor ID
- 105028
- Conditions
- Fabry Disease
- Keywords
- Fabry disease, Young stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 23 Jul 2018 (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.
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients
Detailed description
This is a cross-sectional, population-based study. No randomization procedure will be executed in this study. Approximately 1000 subjects over a 36-month period. The aim of this screening study is to identify the Fabry disease as the cause in patients with young stroke.
To measure the level of α-Gal A activity, male subjects will initially provide a DBS sample and female subjects will start with a test by whole blood sample.
The prevalence of Fabry disease among patients with young stroke will be estimated by a confirmative diagnosis in gene testing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young stroke | – | Genetic: GLA genePatients with acute stroke aged 20 or over, and under 56 years old (Not included 56) . |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young stroke
Key inclusion criteria (4 listed)
- Patients aged 20 or over
- Patients aged under 56 years old, not included 56
- Patients with acute stroke
- Patients and/or their legal representatives are willing to provide written informed consent
Key exclusion criteria (1 listed)
- Patients with a confirmed diagnosis of Fabry disease
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 |
|---|---|---|
| GLA geneGenetic test will be performed when enzyme activity is found abnormal in the whole blood test or confirmation is required. 5 ml of blood sample will be obtained and polymerase chain reaction (PCR) sequencing will be executed to determine mutations in the GLA gene. | Genetic | Young stroke |
Primary outcome
Fabry disease
Time frame: 3 years later
The prevalence of Fabry disease in patients with young stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fabry Disease, run by Chiayi Christian Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fabry disease (time frame: 3 years later). 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 23 Jul 2018.