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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008039
Receipt No. R000009467
Scientific Title QOL research related to liver cysts in patients with ADPKD
Date of disclosure of the study information 2012/05/29
Last modified on 2012/05/28

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Basic information
Public title QOL research related to liver cysts in patients with ADPKD
Acronym QOL of patients with ADPKD liver cyst
Scientific Title QOL research related to liver cysts in patients with ADPKD
Scientific Title:Acronym QOL of patients with ADPKD liver cyst
Region
Japan

Condition
Condition Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
Hepato-biliary-pancreatic medicine Nephrology Urology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the actual conditions of reduced QOL in ADPKD patients with huge liver cysts
Basic objectives2 Others
Basic objectives -Others To investigate the actual conditions of reduced QOL in ADPKD patients with huge liver cysts
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes FANLTC+FACT-Hep additional concerns
Key secondary outcomes To examine the correlation between QOL and other clinical data

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Occupying more than 25% of patients with ADPKD liver cyst
Interventions/Control_2 Occupying less than 25% of patients with ADPKD liver cyst
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
80 years-old >=
Gender Male and Female
Key inclusion criteria ADPKD
20 years of age or older, under the age of 80
Attending physician determines that the case is greater than or equal to 25% of hepatic cysts in the liver parenchyma by CT or MRI
Patients who get written informed consent, and meet all requirements of this test.
Key exclusion criteria Patients with previous liver transplantation
Attending physician determines that the case can not be carried out the
evaluation of the purpose of this study (for example, can not fill out survey QOL).
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Horie
Organization Teikyo University
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku
TEL 03-3964-2497
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Muto
Organization Teikyo University
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku
TEL 03-3964-2497
Homepage URL
Email muto@med.teikyo-u.ac.jp

Sponsor
Institute a Grant-in-Aid for Progressive Renal Diseases Research, from the Ministry of Health, Labour and Welfare of Japan
Institute
Department

Funding Source
Organization a Grant-in-Aid for Progressive Renal Diseases Research, from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 05 Month 29 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
2012 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 28 Day
Last modified on
2012 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009467

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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