Status:
COMPLETED
Global Burden and Treatment Trajectiories in Italian Patients With Fabry Disease
Lead Sponsor:
Chiesi Italia
Conditions:
Fabry Disease
Eligibility:
All Genders
18+ years
Brief Summary
GROUND study is an Italian, multicenter retrospective longitudinal cohort study with a cross-sectional phase with the aim to quantify the severe clinical burden in terms of severe and fatal outcomes a...
Eligibility Criteria
Inclusion
- Adult patients living or deceased of either sex (age ≥18 years) with a documented FD diagnosis in the last 10 years from the beginning of the study.
- Patients with at least 3 years of follow-up or early occurrence of severe/fatal outcomes. Also, adult patients who were lost by their care provider or physician and cannot be traced, but for which it is possible to retrieve data for at least 3 years before the last available follow-up visit or from diagnosis to the occurrence of severe/fatal outcomes if earlier, can be included.
- Written informed consent to undergo in the cross-sectional protocol clinical visit and to retrospectively collect genetic/clinical data. In case of deceased or untraceable patients, the written informed consent is not required to collect retrospective clinical data (excluding genetic data).
Exclusion
- Not applicable
Key Trial Info
Start Date :
June 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04916977
Start Date
June 23 2021
End Date
June 30 2022
Last Update
November 28 2023
Active Locations (7)
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1
AUSL Toscana Sud-Est - Ospedale San Donato
Arezzo, Italy
2
A.O.U. Careggi
Florence, Italy
3
U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo
Monza, Italy
4
U.O. di Nefrologia - Dipartimento di Sanità Pubblica Università degli Studi di Napoli "Federico II" NAPOLI
Napoli, Italy