UMIN-CTR Clinical Trial

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Fujita Health University Research Integrity Office, Quantum Beam DIagnostics

Institute

Department

Personal name



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

2021 Year 03 Month 20 Day

Anticipated trial start date

2021 Year 03 Month 28 Day

Last follow-up date

2027 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

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=R000024929


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name