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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021617
Receipt No. R000024929
Scientific Title Early diagnosis of congenital copper metabolic disorder Wilson disease
Date of disclosure of the study information 2016/03/28
Last modified on 2019/09/27

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Basic information
Public title Early diagnosis of congenital copper metabolic disorder Wilson disease
Acronym Early diagnosis of Wilson disease
Scientific Title Early diagnosis of congenital copper metabolic disorder Wilson disease
Scientific Title:Acronym Early diagnosis of Wilson disease
Region
Japan Asia(except Japan)

Condition
Condition Wilson disease
Classification by specialty
Hepato-biliary-pancreatic medicine Nephrology Neurology
Hepato-biliary-pancreatic surgery Pediatrics Laboratory medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Establishment of early diagnosis methods in Wilson disease by newly developed nano-optical tissue analysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Copper content and distribution in livers of Wilson disease, use biopsied specimens at pre- and post-drug treatment.
Key secondary outcomes Copper content and distribution in livers of non-Wilson disease (WD suspected cases and idiopathic copper toxicosis)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene Device,equipment Maneuver
Other
Interventions/Control_1 Intervention:liver biopsy,
one or two times at pre- and post-treatment to evaluate routine histological diagnostic purpose (in such case, residual specimens will be used as observational study). However, if WD scoring system satisfies, the biopsy may not be mandatory. In such cases (prospective study), the patients's clear understanding and positive agreement with informed consent about the needs of biopsy and enrolment in this study. No intervention for type of drug usage.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Wilson disease (& suspected cases) by liver tests and copper metabolic tests
Key exclusion criteria no
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Matsuura
Organization Fujita Health University
Division name Research Integrity Office, Quantum Beam Diagnostics
Zip code 470-1192
Address 1-98 Kutsukake-cho Toyoake Aichi
TEL 0562-93-2786
Email amatsuu@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Matsuura
Organization Fujita Health University
Division name Research Integrity Office, Quantum Beam Diagnostics
Zip code 470-1192
Address 1-98 Kutsukake-cho Toyoake Aichi
TEL 0562-93-2786
Homepage URL
Email amatsuu@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University Research Integrity Office, Quantum Beam DIagnostics
Institute
Department

Funding Source
Organization Yes
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujita Health University Ethics Review Committee
Address 1-98 Kutsukake-cho, Toyoake City, Aichi
Tel 0562-93-2865
Email f-irb@fujita-hu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 藤田医科大学病院(愛知県) Fujita Health University Hospital (Aichi)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
2016 Year 03 Month 20 Day
Anticipated trial start date
2016 Year 03 Month 28 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Wilson disease is rare genetic disorder, therefore, number of patients and suspected cases are assumed to be small. Because the histological analysis can be applied to pre-existing biopsied samples, patients with WD and suspected cases visited our hospital in last 25 years (apr 1990 to dec 2015) eligible to this study are recruited by outpatient doctors when the patients visit. For old cases, the posters proposing this study are posted for one month. If eligible patients express agreement to enroll, and, if patients who do not anymore visit hospital and do not express exclusion of the use of their samples from this study will be included in histological study. The opt-out recruitment for the use of pre-existing samples (retrospective study) combined with this prospective study has been approved by Fujita Health University Ethics Research Committee.
We are now ready to conduct publicly several tests for decisive diagnosis of Wilson disease. Doctors outside our hospital who see patients with or suspicious to Wilson disease and would like to confirm the diagnosis, please contact with the contact person, Dr Matsuura. Also, we accept patients who would like to consult about your disease or obtain second opinion for your diagnosis, please contact the same person.

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2019 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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