Screening for Fabry Disease in a Pediatric Population at Risk

December 11, 2017 updated by: Markus Ries, MD PhD MHSc FCP, University Hospital Heidelberg
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1422

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • Zentrum für Kinder- und Jugendmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with rheumatological disorders or chronic abdominal pain

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening population
Other: Screening for Fabry disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Fabry disease
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Fabry disease in predefined sub-populations
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (ESTIMATE)

June 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fabry screening 02202014
  • S-084/2014 (OTHER: IRB Heidelberg)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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