A Registered Cohort Study on Wilson's Disease

Sponsor

Wan-Jin Chen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04012658

Collaborator

(none)

2,000

Enrollment

Location

365

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the clinical spectrum and natural progression of Wilson's Disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with Wilson's Disease to optimize clinical management.

Condition or Disease	Intervention/Treatment	Phase
Wilson's Disease	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Registered Cohort Study on Wilson's Disease

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2039

Anticipated Study Completion Date :

Dec 1, 2049

Arms and Interventions

Arm	Intervention/Treatment
Patients with the genetic diagnosis of Wilson's Disease	Other: No intervention No intervention
Asymptomatic Wilson's Disease carriers	Other: No intervention No intervention
Relatives of Wilson's Disease patients or carriers	Other: No intervention No intervention
Unrelated healthy controls	Other: No intervention No intervention

Outcome Measures

Primary Outcome Measures

The change of Unified Wilson's Disease Rating Scale (UWDRS) [Up to 30years]
Disease severity will be assessed by application of the Unified Wilson's Disease Rating Scale (UWDRS), a clinical rating scale consists of three subscales. Higher UWDRS total scores indicate more severe disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with the genetic diagnosis of Wilson's Disease
Asymptomatic Wilson's Disease carriers
Relatives of Wilson's Disease patients or carriers
Unrelated healthy controls
Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

Participants are unable to comply with study procedures and visit schedule

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Fujian Medical University	Fuzhou		China

Sponsors and Collaborators

Wan-Jin Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wan-Jin Chen, The Vice-Director for the Department of Neurology, First Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT04012658

Other Study ID Numbers:

MRCTA,ECFAH OF FMU[2019]197

First Posted:

Jul 9, 2019

Last Update Posted:

Sep 23, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wan-Jin Chen, The Vice-Director for the Department of Neurology, First Affiliated Hospital of Fujian Medical University

Wilson's Disease

Nature history

Genetics

Additional relevant MeSH terms:

Hepatolenticular Degeneration

Study Results

No Results Posted as of Sep 23, 2019