Wilson DiseaseWIL-FRNCT05231876
French Wilson Disease Registry
An observational study of Wilson Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients… Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Wilson Disease
- What is being tested?
- Recording of pathology-related information on the Wilson Register
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2005to 1 Jan 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients suffering from Wilson disease
Who may be able to join
- All patients suffering from Wilson disease
Who cannot join
- Lack of written consent from the patient or their legal representative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
Aurélia Poujois, MD, PhD, (0)148036656 ext. +33, apoujois@for.paris
Amélie Yavchitz, MD, PhD, (0)148036454 ext. +33, ayavchitz@for.paris
About this study
Official title: Registre Wilson France
This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients consulting in France. This database will also make it possible to know all the therapies prescribed to "Wilsonian" patients. The genetic study of these patients will make it possible to specify the various genetic mutations involved in Wilson's disease. The information (clinical, biological, radiological and genetic) relating to the disease will be entered by a doctor or a professional specialising in Wilson's disease.
- Conditions
- Wilson Disease
- Being tested
- Recording of pathology-related information on the Wilson Register
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of pathology-related information on the Wilson RegisterOther
Age, gender, date of diagnosis, clinical symptoms, ethnic charateristics and family tree will be collected and recorded on the Wilson Register during routine clinical care
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of pathology-related information on the Wilson Register
The patient's age, sex, date of diagnosis, clinical symptoms, family tree and ethnic characteristics are collected by a physician or professional specialising in Wilson's disease during a routine care consultation.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2005
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231876
- Sponsor's protocol ID
- CD/EB_19-003_APS
- Acronym
- WIL-FR
- Status last verified
- Jun 2024
- First submitted
- 4 Feb 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registre Wilson France
- ClinicalTrials.gov ID
- NCT05231876
- Acronym / sponsor ID
- WIL-FR / CD/EB_19-003_APS
- Conditions
- Wilson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients consulting in France. This database will also make it possible to know all the therapies prescribed to "Wilsonian" patients. The genetic study of these patients will make it possible to specify the various genetic mutations involved in Wilson's disease. The information (clinical, biological, radiological and genetic) relating to the disease will be entered by a doctor or a professional specialising in Wilson's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients suffering from Wilson disease
Key inclusion criteria (1 listed)
- All patients suffering from Wilson disease
Key exclusion criteria (1 listed)
- Lack of written consent from the patient or their legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of pathology-related information on the Wilson RegisterAge, gender, date of diagnosis, clinical symptoms, ethnic charateristics and family tree will be collected and recorded on the Wilson Register during routine clinical care | Other | – |
Primary outcome
Recording of pathology-related information on the Wilson Register
Time frame: 1 hour
The patient's age, sex, date of diagnosis, clinical symptoms, family tree and ethnic characteristics are collected by a physician or professional specialising in Wilson's disease during a routine care consultation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Wilson France RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélia Poujois, MD, PhD ((0)148036656 ext. +33, apoujois@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of pathology-related information on the Wilson Register (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.