UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021616 |
|---|---|
| Receipt number | R000024895 |
| Scientific Title | Early diagnosis of inherited metabolic disorder of copper Wilson disease |
| Date of disclosure of the study information | 2016/03/28 |
| Last modified on | 2024/03/31 14:32:52 |
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Basic information
Public title
Early diagnosis of inherited metabolic disorder of copper Wilson disease
Acronym
Early diagnosis of Wilson disease
Scientific Title
Early diagnosis of inherited metabolic disorder of copper 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 |
| Pediatrics | Laboratory medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish early diagnostic method for Wilson disease by using biopsied tissue samples
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
Key secondary outcomes
Copper content and distribution in livers of non-Wilson disease (WD suspected cases).
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
| Device,equipment | Maneuver |
Interventions/Control_1
Nanooptics. Intervention:liver biopsy,one or two times at the routine biopsy for diagnostic purpose (in such case, residual specimens will be used as observational study). However,if WD scoring system satisfies, the histological study of biopsied samples 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.
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
5
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
81562932786
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
81562932786
Homepage URL
amatsuu@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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 Aichi
Tel
81 562932865
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
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
| 2021 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2026 | 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 (1990 april to 2015 dec) 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 as same as above.
Management information
Registered date
| 2016 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024895
