Epidemiological Study of Fabry Disease in Taiwan Young St... | NCT03596398

Studies
Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

NCT03596398

Sponsor

Chiayi Christian Hospital

Status

Unknown status

Last Update Posted

Jul 23, 2018Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Fabry Disease

Interventions

GLA gene

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Jun 15, 2018

First Submission Date that Met QC Criteria

Jul 20, 2018

First Posted Date

Jul 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2018

Last Update Posted Date

Jul 23, 2018Actual

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Young stroke		Patients with acute stroke aged 20 or over, and under 56 years old (Not included 56) .	Genetic: GLA gene

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLA gene	Genetic	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fabry disease	The prevalence of Fabry disease in patients with young stroke	3 years later

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with a confirmed diagnosis of Fabry disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Young stroke

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000795	Fabry Disease

Ancestor Terms

ID	Term
D013106	Sphingolipidoses
D020140	Lysosomal Storage Diseases, Nervous System
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000519	alpha-Galactosidase

Ancestor Terms

ID	Term
D005696	Galactosidases
D006026	Glycoside Hydrolases
D006867	Hydrolases
D004798	Enzymes

Browse Leaves

Not provided

Browse Branches

Not provided