Newborn Screening for Adrenoleukodystrophy

NCT ID: NCT02952482

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45796 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-08-31

Brief Summary

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To test if the routine newborn screening dried blood spots can be used to test if elevation of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy (ALD)

Detailed Description

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Parents of newborns will be invited to test if their newborns are affected with ALD. The routine newborn screening dried blood spots sample will be used to test the concentration of C26:0-lyso-PC . If positive of a screening test, further confirmation tests including physical examination and other methodology for ALD confirmation will be provided. Genetic counseling and treatment option will be provided, too.

Conditions

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Adrenoleukodystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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newborns testing for ALD

newborns testing for ALD

newborns testing for ALD

Intervention Type PROCEDURE

Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC

Interventions

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newborns testing for ALD

Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Babies born in Taiwan receive regular newborn screening suggested by Ministry of Heath and Welfare.
* Parents or Legal Guardian sign in the informed consent form.

Exclusion Criteria

* Parents or Legal Guardian do not agree to sign in the informed consent form.
Minimum Eligible Age

2 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201603025RIND

Identifier Type: -

Identifier Source: org_study_id

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