Spanish Wilson Disease Registry | NCT06466291

Studies
Spanish Wilson Disease Registry

NCT06466291

Sponsor

Asociación Española para el Estudio del Hígado

Status

Recruiting

Last Update Posted

Jun 20, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Wilson Disease

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2021Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Jun 14, 2024

First Submission Date that Met QC Criteria

Jun 14, 2024

First Posted Date

Jun 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2024

Last Update Posted Date

Jun 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain.

As secondary objectives, the prevalence and incidence of the disease will be analysed.

Likewise, the analysis aims to define future areas of interest in its pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment.

Improving knowledge at a national level can help to design screening strategies and improve diagnostic circuits.

Detailed Description

Retrospective and prospective study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To know the current status of Wilson Disease in Spain		2025

Secondary Outcomes

Measure	Description	Time Frame
To analyse the prevalence of Wilson Disease in Spain		2025
To analyse the incidence of Wilson Disease in Spain		2025

Other Outcomes

Measure	Description	Time Frame
To define future areas of interest in Wilson Disease	To define future areas of interest in the disease pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment	2025

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a confirmed Wilson Disease diagnosis

Exclusion Criteria:

Refusal to sign the informed consent for the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Wilson Disease patients under follow-up in participating centres in Spain who agree to participate in the registry by signing the informed consent form.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asociación Española para el Estudio del Hígado Asociación Española para el Estudio del Hígado	Contact	0034915551119		registrowilsonaeeh@gmail.com

Overall Officials

Name	Affiliation	Role
Zoe Mariño	Asociación Española para el Estudio del Hígado	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic	Recruiting	Barcelona		08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D006527	Hepatolenticular Degeneration
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D001480	Basal Ganglia Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided