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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 February 2023 |
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Main ID: |
NCT02778295 |
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Date of registration:
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18/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Biomarker for Patients With Fabry Disease (BioFabry)
BioFabry |
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Scientific title:
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Biomarker for Fabry Disease: BioFabry AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL |
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Date of first enrolment:
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August 20, 2018 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02778295 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Algeria
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Brazil
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Egypt
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Germany
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India
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Serbia
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Sri Lanka
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Contacts
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Name:
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Peter Bauer, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centogene GmbH |
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA:
- Informed consent will be obtained from the patient or the parents before any study
related procedures.
- Patients of both genders older than 2 months
- The patient has a diagnosis of Fabry disease or a high-grade suspicion for Fabry
disease
- High-grade suspicion present, if one or more inclusion criteria are valid:
- Positive family anamnesis for Fabry disease
- Pin and burning in the hands and feet
- Angiokeratomas
- Gastrointestinal problems
- Heart problems
- Kidney problems
EXCLUSION CRITERIA:
- No Informed consent from the patient or the parents before any study related
procedures.
- Patients of both gender younger than 2 months
- No diagnosis of Fabry disease or no valid criteria for profound suspicion of Fabry
disease
Age minimum:
2 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Hearing Loss
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Angiokeratomas
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Ocular Abnormalities
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Primary Outcome(s)
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Sequencing of the Fabry disease related gene
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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The Fabry disease specific biomarker candidates finding
[Time Frame: 24 months]
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Secondary ID(s)
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BFA 06-2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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