A Registered Cohort Study on Wilson's Disease

September 19, 2019 updated by: Wan-Jin Chen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
      • Fuzhou, China
        • Recruiting
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Jin He, MD
        • Contact:
        • Principal Investigator:
          • Wan-Jin Chen, MD, PhD
        • Sub-Investigator:
          • Ning Wanf, MD,PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Wilson's Disease are diagnosed by the clinical and/or genetic features

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unrelated healthy controls
Other: No intervention
No intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of Unified Wilson's Disease Rating Scale (UWDRS)
Time Frame: 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.
Up to 30years

Collaborators and Investigators

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

Sponsor

Wan-Jin Chen

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 (Actual)

July 1, 2019

Primary Completion (Anticipated)

December 1, 2039

Study Completion (Anticipated)

December 1, 2049

Study Registration Dates

First Submitted

July 6, 2019

First Submitted That Met QC Criteria

July 6, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH OF FMU[2019]197

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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