Unique ID issued by UMIN | UMIN000021617 |
---|---|
Receipt number | 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 | 2024/03/31 14:31:50 |
Early diagnosis of congenital copper metabolic disorder Wilson disease
Early diagnosis of Wilson disease
Early diagnosis of congenital copper metabolic disorder Wilson disease
Early diagnosis of Wilson disease
Japan | Asia(except Japan) |
Wilson disease
Hepato-biliary-pancreatic medicine | Nephrology | Neurology |
Hepato-biliary-pancreatic surgery | Pediatrics | Laboratory medicine |
Others
YES
Establishment of early diagnosis methods in Wilson disease by newly developed nano-optical tissue analysis
Efficacy
Confirmatory
Pragmatic
Not applicable
Copper content and distribution in livers of Wilson disease, use biopsied specimens at pre- and post-drug treatment.
Copper content and distribution in livers of non-Wilson disease (WD suspected cases and idiopathic copper toxicosis)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Gene | Device,equipment | Maneuver |
Other |
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.
1 | years-old | <= |
100 | years-old | >= |
Male and Female
Wilson disease (& suspected cases) by liver tests and copper metabolic tests
no
10
1st name | Akihiro |
Middle name | |
Last name | Matsuura |
Fujita Health University
Research Integrity Office, Quantum Beam Diagnostics
470-1192
1-98 Kutsukake-cho Toyoake Aichi
0562-93-2786
amatsuu@fujita-hu.ac.jp
1st name | Akihiro |
Middle name | |
Last name | Matsuura |
Fujita Health University
Research Integrity Office, Quantum Beam Diagnostics
470-1192
1-98 Kutsukake-cho Toyoake Aichi
0562-93-2786
amatsuu@fujita-hu.ac.jp
Fujita Health University Research Integrity Office, Quantum Beam DIagnostics
Yes
Japanese Governmental office
Japan
Fujita Health University Ethics Review Committee
1-98 Kutsukake-cho, Toyoake City, Aichi
0562-93-2865
f-irb@fujita-hu.ac.jp
NO
藤田医科大学病院(愛知県) Fujita Health University Hospital (Aichi)
2016 | Year | 03 | Month | 28 | Day |
Unpublished
Open public recruiting
2015 | Year | 11 | Month | 20 | Day |
2021 | Year | 03 | Month | 20 | Day |
2021 | Year | 03 | Month | 28 | Day |
2027 | Year | 03 | Month | 31 | Day |
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.
2016 | Year | 03 | Month | 25 | Day |
2024 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024929
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