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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032010
Receipt No. R000036532
Scientific Title Genetic studies of polycystic livers
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/15

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Basic information
Public title Genetic studies of polycystic livers
Acronym Genetic studies of polycystic livers
Scientific Title Genetic studies of polycystic livers
Scientific Title:Acronym Genetic studies of polycystic livers
Region
Japan

Condition
Condition Polycystic livers
Classification by specialty
Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Examine the genetic mutations and these clinical characteristics in polycystic liver diseases
Basic objectives2 Others
Basic objectives -Others Examine the genetic mutations and these clinical characteristics in polycystic liver diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Liver volume, Survivals
Key secondary outcomes Hospitalization, Complications

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 Genetic testing
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed polycystic liver diseases
Key exclusion criteria Patients under 20 year-old
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Hoshino
Organization Toranomon Hospital
Division name Nephrology Center
Zip code 1058470
Address 2-2-2
TEL 0335881111
Email hoshino@toranomon.gr.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Hoshino
Organization Toranomon Hospital
Division name Nephrology Center
Zip code 1058470
Address 2-2-2, Minato-ku, Toranomon
TEL 0335881111
Homepage URL
Email jhoshino-ind@umin.ac.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toranomon Hospital
Address 2-2-2, Toranomon, Minato-ku
Tel 0335881111
Email chiken-jim2@toranomon.gr.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

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 29 Day
Date of IRB
2018 Year 07 Month 10 Day
Anticipated trial start date
2018 Year 07 Month 10 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036532

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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