UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008039 |
|---|---|
| Receipt number | 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 12:20:38 |
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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
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
muto@med.teikyo-u.ac.jp
Sponsor or person
Institute
a Grant-in-Aid for Progressive Renal Diseases Research, from the Ministry of Health, Labour and Welfare of Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009467
