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Screening for Fabry Disease in a Pediatric Population at Risk

NCT ID: NCT02152189

Last Updated: 2017-12-13

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

1422 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is to assess the frequency of Fabry disease in children with chronic abdominal pain or chronic pain in the extremities

Detailed Description

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Conditions

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Chronic Pain in the Extremities Chronic Abdominal Pain Fabry Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Screening population

Screening for Fabry disease

Intervention Type OTHER

Interventions

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Screening for Fabry disease

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age below 18 years
* One of the following criteria:

* Diagnosis or suspicion of a rheumatological disorder with recurrent complaints for more than 6 months
* Chronic, recurrent abdominal pain for more than 6 months
* Planned blood sample for routine diagnostics
* Written informed consent

Exclusion Criteria

\- Patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Markus Ries, MD PhD MHSc FCP

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zentrum für Kinder- und Jugendmedizin

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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Ries M, Gupta S, Moore DF, Sachdev V, Quirk JM, Murray GJ, Rosing DR, Robinson C, Schaefer E, Gal A, Dambrosia JM, Garman SC, Brady RO, Schiffmann R. Pediatric Fabry disease. Pediatrics. 2005 Mar;115(3):e344-55. doi: 10.1542/peds.2004-1678. Epub 2005 Feb 15.

Reference Type BACKGROUND
PMID: 15713906 (View on PubMed)

Kastner B, Behre S, Lutz N, Burger F, Luntz S, Hinderhofer K, Bendszus M, Hoffmann GF, Ries M. Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses. PLoS One. 2015 Aug 14;10(8):e0135997. doi: 10.1371/journal.pone.0135997. eCollection 2015.

Reference Type DERIVED
PMID: 26275228 (View on PubMed)

Other Identifiers

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S-084/2014

Identifier Type: OTHER

Identifier Source: secondary_id

Fabry screening 02202014

Identifier Type: -

Identifier Source: org_study_id